BD Insyte W™ Peripheral Venous Catheter 20G x 1.16 in (1.1 mm x 30 mm) with Wings
Becton Dickinson
Medical device – peripheral IV catheterPeripheral venous catheter with wings (over-the-needle, non-safety)
Certifications
- CE Marked as a medical device under applicable EU and UK medical device legislation (CE mark with appropriate notified body identification on labelling).
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Materials and design evaluated for biocompatibility in accordance with ISO 10993 series standards for devices with blood and tissue contact.
- Sterilisation process validated to an accepted sterility assurance level in accordance with relevant ISO and EN standards for terminally sterilised medical devices.
- Designed and tested in line with applicable ISO and EN standards for intravascular catheters and Luer connectivity.
- MR Conditional status as described in the BD Insyte™ Instructions for Use, with specified scanning conditions for safe MRI exposure.
- CE Marked as a medical device under applicable EU and UK medical device legislation (CE mark with appropriate notified body identification on labelling).
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Materials and design evaluated for biocompatibility in accordance with ISO 10993 series standards for devices with blood and tissue contact.
- Sterilisation process validated to an accepted sterility assurance level in accordance with relevant ISO and EN standards for terminally sterilised medical devices.
- Designed and tested in line with applicable ISO and EN standards for intravascular catheters and Luer connectivity.
- MR Conditional status as described in the BD Insyte™ Instructions for Use, with specified scanning conditions for safe MRI exposure.
Peripheral venous catheter with wings (over-the-needle, non-safety)
Description
The BD Insyte-W™ Peripheral Venous Catheter 20G x 1.16 in (1.1 mm x 30 mm) is a sterile, single-use, over-the-needle peripheral IV catheter with integrated wings for securement. It is designed for short-term intravascular access to administer IV fluids, medications, blood, and blood products, or to sample blood. The catheter is made from BD Vialon™ biomaterial, a radiopaque polyurethane that softens in the vein after insertion, helping to improve patient comfort, reduce mechanical phlebitis, and support longer dwell times compared with traditional FEP catheters. The 20G x 1.16 in variant (REF 381334) provides a good balance of flow rate and vein preservation, and is colour-coded pink for easy gauge identification. Each catheter is individually packaged, latex-free and DEHP-free, and supplied in boxes of 50 or 200 for use in hospital and clinical environments.
Bnefits
- Uses BD Vialon™ radiopaque biomaterial, which softens in the vein after insertion and is associated with reduced mechanical phlebitis and longer potential dwell times compared with FEP catheters.
- Winged design provides a broad, stable surface area that facilitates taping and securement, helping to reduce catheter movement and risk of dislodgement.
- Radiopaque catheter body improves visibility under X-ray, aiding confirmation of catheter location when imaging is performed.
- Standardised 20G x 1.16 in size (1.1 mm x 30 mm) offers a versatile combination of adequate flow and suitability for a wide range of adult peripheral veins.
- Designed for smooth insertion with a sharp stainless-steel needle and lubricated catheter, supporting first-attempt success and minimising patient discomfort.
- Colour-coded hub and wings (pink for 20G) support quick and accurate gauge identification in busy clinical settings.
- Compatible with standard ISO-compliant Luer connections, allowing integration with commonly used IV lines, extension sets and accessories.
- Latex-free and DEHP-free construction reduces potential risk for latex and phthalate sensitivities.
- Validated sterile, single-use device with comprehensive BD instructions for use and global regulatory compliance.
Indications
- Short-term peripheral intravenous cannulation for administration of IV fluids, medications, blood and blood components in patients where a 20G catheter is clinically appropriate.
- Peripheral venous access for blood sampling where permitted by institutional policy and local practice.
- Monitoring and treatment in general medical, surgical, emergency, perioperative, outpatient and day-case settings requiring routine peripheral IV access.
- Use in any patient population (adult or paediatric) where vascular anatomy and clinical condition are suitable for a 20G winged peripheral IV catheter.
Composition
- Catheter: BD Vialon™ radiopaque polyurethane biomaterial, colour coded pink for 20G.
- Needle: Stainless steel hypodermic cannula with bevelled tip designed for intravascular access.
- Catheter hub: Medical-grade, colour-coded polymer hub providing a standard Luer connection.
- Wings: Integrated polymer wings attached to the catheter hub to support stabilisation and securement.
- Flash chamber: Transparent polymer housing with removable vent plug to confirm venous entry through blood flashback.
- Lubricant: Medical-grade silicone-based lubricant on the needle/catheter interface to allow smooth advancement and withdrawal.
- Radiopacifier: Radiopaque filler (e.g., barium sulfate) incorporated in BD Vialon™ catheter material to enable X-ray visualisation.
- Latex status: Latex-free; natural rubber latex is not intentionally used in the device or primary packaging materials.
- Plasticiser status: Fluid path components are manufactured without the use of DEHP, in line with BD’s low-plasticiser design for vascular access devices.
Formulation
- Device type: Over-the-needle, non-safety peripheral IV catheter with integrated wings (Insyte-W™ configuration).
- Gauge and length: 20 gauge catheter, 1.16 inches (30 mm) in length, nominal outer diameter 1.1 mm.
- Catalogue / reference number: 381334 (BD Insyte-W™ IV Catheter with Wings 20G x 1.16 in).
- Catheter inner diameter: Approximately 0.0300–0.0330 in (0.762–0.838 mm), supporting typical gravity flow rates suitable for routine infusions.
- Catheter outer diameter: Approximately 0.0410–0.0440 in (around 1.04–1.12 mm).
- Flow rate: Typical gravity flow rate around 60 mL/min for standard IV fluids (approximate, derived from manufacturer catalogue data for this configuration).
- Catheter material: BD Vialon™ biomaterial, a radiopaque polyurethane designed to soften in vivo.
- Hub and wing colour: Pink, indicating 20G according to international colour-coding conventions for IV catheters.
- Power injection: 20G BD Insyte devices are suitable for use with power injectors up to a maximum pressure of 300 psi (2068 kPa) when used according to the BD Insyte Instructions for Use and relevant power injection guidelines.
- Regulatory class: CE-marked peripheral intravascular catheter (EU/UK medical device regulations; typically Class IIa).
- Sterilisation: Terminally sterilised single-use device, sterilisation method validated to an accepted sterility assurance level.
Packaging
- Primary pack: Individual sterile blister or peel pouch containing one BD Insyte-W™ 20G x 1.16 in catheter with needle and flash chamber, single-use.
- Shelf pack: Boxes typically containing 50 individually wrapped catheters (as per BD shelf GTIN data).
- Shipping case: Outer case generally containing 200 catheters (4 shelf packs of 50) for bulk distribution.
- Labelling: Each unit and outer carton labelled with product name, gauge and length (20G x 1.16 in / 1.1 mm x 30 mm), REF 381334, GTIN identifiers, lot number, expiry date, sterilisation method, single-use symbol, CE mark and other mandatory regulatory symbols.
- Protection: Packaging designed to protect the device from mechanical damage, moisture and contamination, maintaining sterility through stated shelf life under recommended storage conditions.
Usage
- Before use, inspect the sterile package for any signs of damage, moisture or tampering. Do not use if the package is opened, damaged or beyond the expiry date.
- Perform hand hygiene and don appropriate personal protective equipment according to institutional protocols.
- Select an appropriate peripheral vein and insertion site based on therapy type, expected duration and patient-specific factors.
- Prepare the skin with an appropriate antiseptic agent and allow it to dry completely, following local infection prevention guidelines.
- Open the sterile package aseptically and remove the catheter assembly by the hub and wings, avoiding contamination of the catheter and needle.
- Remove the needle cover in a straight motion while keeping the needle protected from non-sterile surfaces.
- Stabilise the chosen vein and insert the catheter/needle assembly bevel up at an appropriate angle, advancing until blood flashback is observed in the flash chamber, indicating venous entry.
- Lower the insertion angle and advance the catheter slightly to ensure the catheter tip is fully within the vein while avoiding over-penetration.
- Using the wings and hub for control, advance the catheter off the needle into the vein while keeping the needle position stable; do not reinsert the needle into the catheter at any time.
- Apply gentle pressure to the vein just proximal to the catheter tip to reduce blood leakage while disconnecting the needle and attaching extension sets or IV lines, following facility protocol.
- Dispose of the used needle immediately in an approved sharps container without recapping.
- Connect the catheter hub to a compatible Luer device (e.g., extension set or infusion line), ensure the connection is secure, and flush the catheter to confirm patency and correct placement.
- Secure the catheter with an appropriate sterile dressing and any additional stabilisation devices; label the dressing with insertion date, time and other required details.
- Monitor the insertion site regularly for signs of phlebitis, infiltration, infection, leakage or dislodgement, and replace or remove the catheter according to institutional policy or if complications arise.
- After therapy completion 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, intra-cardiac, spinal, epidural or intraosseous use; this device is designed for peripheral venous access only.
- Do not use if the sterile package is open, damaged, wet or beyond the indicated expiry date.
- Do not reuse or resterilise; reuse can lead to infection, device malfunction or compromised sterility.
- Do not reinsert the needle into the catheter once withdrawn, as this may damage or shear the catheter and increase the risk of catheter embolism.
- Avoid insertion at sites with active infection, thrombosis, compromised skin integrity, burns or significant oedema unless benefits outweigh risks and no alternative site is available.
- Use with power injectors only within the gauge, length and pressure limits specified in the BD Insyte™ Instructions for Use; exceeding recommended parameters may result in catheter failure or vessel injury.
Adverse Effects
- Local site reactions such as pain, tenderness, erythema, swelling, bruising or haematoma at the insertion site.
- Mechanical or chemical phlebitis, characterised by warmth, redness, pain and a palpable cord along the vein.
- Infiltration or extravasation of infusate into surrounding tissues, potentially leading to local tissue damage depending on the solution or drug.
- Catheter-related infection or local cellulitis if aseptic technique and maintenance protocols are not followed.
- Catheter occlusion or difficulty flushing and infusing due to thrombus formation or kinking.
- Rare risk of catheter fragment embolisation if improper attempts are made to reinsert the needle into a partially advanced catheter.
- Air embolism or thromboembolic events if the device and associated tubing are not properly primed and secured.
- Systemic adverse effects related to the infused drugs or fluids (e.g., allergic reactions, fluid overload), attributable to the therapy rather than the catheter itself.
Storage Conditions
- Store in the original packaging in a clean, dry location.
- Keep at normal room temperature within the range specified on the product labelling; avoid excessive heat, freezing and high humidity.
- Protect from direct sunlight, dust and physical damage that could compromise the packaging or device.
- Do not use after the expiry date printed on the packaging.
- Keep out of reach of children and unauthorised personnel.
- Avoid storing near chemicals or volatile substances that could damage packaging or device materials.
Duration
Intended as a short-term intravascular catheter for use of less than 30 days. Actual dwell time depends on clinical condition, site assessment and institutional policy, with many facilities reviewing peripheral IV catheters at least every 72\u201396 hours or sooner if signs of complications appear.
Onset
Not directly applicable to the catheter itself; onset of clinical effect is determined by the properties and administration of the infused medication or fluid rather than the device.
