BD Integrated Cannula Green 18G x 1.0\ with Y Connector (BD Saf T Intima™ Safety System)
Becton Dickinson
Medical device – peripheral IV catheterIntegrated closed IV catheter with wings, extension tubing and Y adapter
Certifications
- CE Marked as a medical device under applicable EU and UK medical device regulations for peripheral intravascular catheters.
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Materials evaluated for biocompatibility in accordance with ISO 10993 series standards for devices with intravascular and tissue contact.
- Sterilisation process validated to an appropriate sterility assurance level in line with ISO and EN standards for terminally sterilised single Use medical devices.
- Design and performance consistent with relevant ISO/EN standards for intravascular catheters, Luer/connector performance and safety Engineered sharps devices.
- Latex Free design in line with regulatory guidance to minimise exposure to natural rubber latex in medical devices.
- CE Marked as a medical device under applicable EU and UK medical device regulations for peripheral intravascular catheters.
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Materials evaluated for biocompatibility in accordance with ISO 10993 series standards for devices with intravascular and tissue contact.
- Sterilisation process validated to an appropriate sterility assurance level in line with ISO and EN standards for terminally sterilised single Use medical devices.
- Design and performance consistent with relevant ISO/EN standards for intravascular catheters, Luer/connector performance and safety Engineered sharps devices.
- Latex Free design in line with regulatory guidance to minimise exposure to natural rubber latex in medical devices.
Integrated closed IV catheter with wings, extension tubing and Y adapter
Description
The BD Integrated Cannula Green 18G x 1.0\ with Y Connector is the BD Saf-T-Intima™ Safety System configured as an 18-gauge, 1-inch integrated closed IV catheter with wings, extension tubing and Y adapter. It is an over-the-needle catheter made from radiopaque BD Vialon™ biomaterial and incorporates a safety-engineered telescoping needle shield that passively covers the needle upon withdrawal, helping to protect clinicians from needlestick injury. The preattached extension tubing and Y adapter create a closed system designed to contain blood within the device during insertion, reducing blood exposure and supporting cleaner, virtually bloodless procedures. The system includes textured wings for catheter control and securement, an integrated clamp, pre-attached BD PRN adapter or Y connector, vent plug (for Y-adapter configurations) and needle cover, and is supplied sterile for single use.
Bnefits
- Closed IV catheter system with preattached extension tubing and Y adapter designed to contain blood within the device and reduce blood exposure during insertion.
- Telescoping needle shield that passively covers the needle as it is withdrawn, helping to protect healthcare workers from accidental needlestick injuries without requiring additional activation steps near the patient.
- Catheter made from BD Vialon™ biomaterial, a radiopaque polyurethane designed to soften in situ, which is associated with improved patient comfort, reduced mechanical phlebitis and the potential for longer dwell times compared with traditional FEP catheters.
- Integrated design with wings and extension tubing allows manipulation and line access to occur further from the insertion site, which may help to reduce catheter movement and dislodgement.
- Flexible, textured wings provide confident catheter control during insertion and a broad base for low-profile taping and securement, enhancing patient comfort and stability.
- Y adapter with clamp supports connection of multiple lines or needle-free connectors in accordance with institutional practice, offering versatility for medication administration and flushing.
- Pre-attached PRN or Y adapter and vent plug support a closed, air-managed system and simplify setup, reducing the need for separate components and assembly.
- Radiopaque catheter material improves visibility under X-ray, aiding confirmation of catheter location when imaging is performed.
- Single-use, latex-free design supports infection prevention and reduces the risk of latex-related hypersensitivity reactions.
- Part of the BD Saf-T-Intima™ family, providing a consistent safety and performance profile across different gauges and configurations.
Indications
- Short-term peripheral intravenous catheterisation to administer IV fluids, medications, blood and blood products in adult and appropriate paediatric patients where an 18G catheter is clinically indicated.
- Peripheral IV access for blood sampling where permitted by local policy and compatible with device and institutional guidelines.
- Use in clinical environments where a closed IV catheter system is preferred to minimise blood exposure during insertion and connection of extension sets or infusion lines.
- Situations requiring a safety-engineered peripheral IV catheter with passive needle protection to help reduce needlestick injuries among healthcare workers.
Composition
- Catheter: BD Vialon™ radiopaque polyurethane catheter in 18 gauge x 1.00 inch (green colour coding for 18G), designed to soften in situ for improved comfort and dwell time.
- Needle: Stainless steel over-the-needle stylet with a sharp bevel tip, attached to an internal wire stylet for stability during insertion.
- Needle shield: Telescoping needle shield mechanism integrated into the device that passively covers the needle upon withdrawal.
- Wings: Flexible, textured polymer wings attached to the hub to aid insertion, provide a broad taping surface and support securement.
- Extension tubing: Integrated, flexible clear tubing (short length) attached to the catheter hub, forming part of the closed system and incorporating a slide clamp.
- Y adapter: Integrated Y connector at the distal end of the extension tubing to facilitate multiple line access or connection of needle-free devices.
- Clamp: Slide clamp on the extension tubing used to open or close the line and control fluid flow during setup and therapy.
- Vent plug: Vent plug component (for Y-adapter configurations) to manage air and blood during priming and connection.
- PRN adapter / connector: Preattached BD PRN adapter or interface at the distal end of the Y adapter, compatible with ISO-compliant needleless connectors according to configuration.
- Needle cover: Rigid protective needle cover enclosing the needle and catheter assembly prior to use to maintain sterility.
- Materials status: Latex-free; natural rubber latex is not intentionally used in the device or primary packaging materials.
Formulation
- Device type: Integrated, closed, over-the-needle safety IV catheter system with wings, extension tubing and Y adapter (BD Saf-T-Intima™ configuration).
- Gauge and length: 18 gauge catheter, 1.00 inch nominal length (green-coded, approximately 1.3 mm outer diameter and 25 mm length).
- Catalogue / reference number: 383346 (BD Saf-T-Intima™ Safety System with BD Vialon™ Catheter Material and Y Adapter, 18 G x 1.00 in).
- Catheter material: BD Vialon™ radiopaque polyurethane biomaterial designed to soften after insertion and improve patient comfort.
- Hub and wing colour: Green hub and wings corresponding to 18G according to international colour coding for peripheral IV catheters.
- System configuration: Integrated catheter with preattached short extension tubing, slide clamp, Y adapter, PRN adapter/connector, vent plug (Y configuration), telescoping needle shield and protective cover.
- Safety mechanism: Passive telescoping needle shield that automatically covers the needle when it is withdrawn from the catheter, without requiring separate activation steps at the insertion site.
- Sterilisation: Terminally sterilised single-use device, with sterility assurance according to recognised medical device sterilisation standards.
- Regulatory class: Peripheral intravascular catheter system marketed as a CE-marked medical device in the EU/UK and as a Class II device (FOZ) in other regulated markets.
- Intended fluid path: Compatible with commonly used IV solutions and medications in line with BD’s material compatibility guidance and institutional protocols.
Packaging
- Primary packaging: Individual sterile blister or peel pouch containing one BD Saf-T-Intima™ 18G x 1.0" catheter system with wings, extension tubing, clamp, Y adapter, PRN adapter/connector, vent plug (where applicable), needle and needle shield.
- Box configuration: 25 individually packaged catheter systems per box, as listed by Medisave and other distributors.
- Case configuration: Typically 8 boxes per shipping case (200 catheter systems per case) for bulk distribution, as reflected in third-party distributor listings.
- Labelling: Each unit and outer carton labelled with product name, gauge and length (18G x 1.0 in / green), catalogue number (383346), lot number, expiry date, sterility symbol, single-use symbol, CE mark and other mandatory regulatory symbols and product identifiers.
- Protection: Packaging designed to protect the catheter system from mechanical damage, moisture and contamination prior to use while maintaining sterility up to the labelled expiry date.
Usage
- Verify that the sterile package is intact and within its expiry date. Do not use if the pouch is open, damaged or expired.
- Perform hand hygiene and don appropriate personal protective equipment according to institutional and infection prevention policies.
- Prepare all necessary equipment for IV cannulation, including skin antiseptic, dressings, flush solution, and any required infusion sets or needleless connectors.
- Select an appropriate peripheral vein and insertion site based on clinical assessment, therapy requirements and institutional guidelines.
- Clean the skin at the chosen site with an appropriate antiseptic solution and allow it to dry completely before insertion.
- Open the BD Saf-T-Intima™ package aseptically and remove the device by the wings or extension set, avoiding contact with the catheter and needle.
- Ensure the slide clamp on the extension tubing is closed before insertion to maintain a closed system and minimise blood exposure.
- Remove the needle cover carefully, keeping the needle and catheter assembly sterile and avoiding contact with non-sterile surfaces.
- Stabilise the vein and insert the cannula bevel up at an appropriate angle; advance the catheter/needle assembly until blood flashback is seen and the catheter tip is judged to be within the vessel lumen.
- Lower the insertion angle and advance the catheter slightly to ensure the catheter is fully in the vein while minimising vessel trauma.
- Advance the catheter off the needle into the vein by holding the wings and gently sliding the catheter forward while maintaining needle stability; do not reinsert the needle into the catheter once withdrawn.
- Withdraw the needle fully from the catheter; the telescoping needle shield will passively cover the needle as it is removed. Verify that the needle is completely shielded and immediately discard the protected needle in an approved sharps container.
- Maintain control of the extension tubing and Y adapter to minimise blood leakage. Connect the distal adapter or Y connection to a primed IV set or needle-free connector in accordance with facility protocols, then open the slide clamp and flush to confirm patency and correct placement.
- Secure the catheter and wings to the skin with an appropriate sterile dressing and any additional stabilisation devices. Label the dressing with insertion date, time and other required identification.
- Monitor the site regularly for signs of infiltration, phlebitis, infection, leakage or dislodgement, and manage according to institutional policies.
- When IV therapy is complete or if complications occur, remove the catheter following standard procedures, apply pressure until haemostasis is achieved and cover with a suitable dressing.
Contraindications
- Do not use in patients with known or suspected hypersensitivity to polyurethane (BD Vialon™), stainless steel, or other device materials when such allergies are clinically significant.
- Not intended for arterial, intracardiac, epidural, spinal, intraosseous or other non-peripheral venous access routes.
- Do not use if the sterile package is open, torn, wet, contaminated or past the indicated expiry date.
- Do not reuse, reprocess or resterilise; reuse may cause infection, device malfunction or compromised safety performance.
- Do not reinsert the needle into the catheter after partial advancement or withdrawal, as this may damage the catheter and increase the risk of catheter embolism.
- Avoid use at sites with active infection, significant skin damage, burn, thrombosis or severe oedema unless no alternative access site is available and the benefits clearly outweigh risks.
- Use with power injectors or high-pressure systems only if the specific catheter configuration is validated and labelled for such use; otherwise, power injection may be contraindicated.
Adverse Effects
- Local insertion site reactions, including pain, tenderness, erythema, swelling, bruising or haematoma.
- Mechanical or chemical phlebitis, presenting with warmth, redness, pain and a palpable venous cord near the catheterised vein.
- Infiltration or extravasation of infusate into surrounding tissue if catheter position is compromised, which may lead to local tissue damage depending on the solution or medication.
- Catheter-related infection, local cellulitis or, rarely, bloodstream infection if aseptic technique and maintenance protocols are not followed.
- Catheter occlusion or difficulty flushing or infusing due to thrombus formation, kinking or precipitate formation within the catheter.
- Rare risk of catheter fragment embolisation if the catheter is damaged or if the needle is forced back into an in-situ catheter.
- Air embolism or thromboembolic events if the catheter and associated tubing are not correctly primed, secured and managed according to protocol.
- Systemic adverse effects attributable to infused medications (e.g., hypersensitivity reactions, fluid overload), which are related to the therapy rather than to the catheter itself.
Storage Conditions
- Store the catheter systems in their original packaging in a clean, dry area.
- Maintain storage within the temperature and humidity ranges specified on the product labelling; avoid excessive heat, freezing and high humidity.
- Protect from direct sunlight and from sources of ozone or chemicals that could degrade packaging or device materials.
- Handle shipping cartons carefully to prevent crushing, puncture or other mechanical damage that could compromise sterility.
- Do not use after the expiry date printed on the packaging.
- Keep out of reach of children and unauthorised personnel.
Duration
Intended for short-term intravascular use (typically less than 30 days). Actual dwell time is determined by clinical assessment, type of therapy, insertion site condition and institutional policy, with regular site review and replacement if complications or signs of phlebitis, infiltration or infection occur.
Onset
Not applicable to the device itself. The onset, peak and duration of clinical effect depend on the pharmacological properties, dose and route of the infused medication or fluid rather than the BD Saf-T-Intima\u2122 catheter system.
