B. Braun Introcan Safety 3 PUR IV Catheter 18G 45mm Green
B. Braun
Injection & InfusionPeripheral IV catheter \u2013 closed safety IV catheter with blood control
Certifications
- Manufactured under an ISO 13485 Certified quality management system for medical devices by B. Braun.
- Peripheral IV catheter designed and tested according to relevant ISO standards for intravascular catheters and Luer connectors.
- CE Marked as a medical device within the European Economic Area and UK, with classification appropriate to sterile single Use invasive devices for short Term intravascular use.
- FDA 510(k) cleared as the Introcan Safety 3 Closed IV Catheter in the United States, indicating substantial equivalence to legally marketed devices and compliance with applicable US regulatory requirements.
- Latex , PVC and DEHP Free construction, as stated in product and marketing literature, supporting use in patients with sensitivities to these materials.
- Manufactured under an ISO 13485 Certified quality management system for medical devices by B. Braun.
- Peripheral IV catheter designed and tested according to relevant ISO standards for intravascular catheters and Luer connectors.
- CE Marked as a medical device within the European Economic Area and UK, with classification appropriate to sterile single Use invasive devices for short Term intravascular use.
- FDA 510(k) cleared as the Introcan Safety 3 Closed IV Catheter in the United States, indicating substantial equivalence to legally marketed devices and compliance with applicable US regulatory requirements.
- Latex , PVC and DEHP Free construction, as stated in product and marketing literature, supporting use in patients with sensitivities to these materials.
Peripheral IV catheter \u2013 closed safety IV catheter with blood control
Description
The B. Braun Introcan Safety 3 PUR IV Catheter - 18G - 45mm - Green is a closed peripheral intravenous (IV) catheter made from polyurethane (PUR) that softens at body temperature to enhance patient comfort and help reduce phlebitis risk and extend indwell time. This 18G (1.3 x 45 mm) green-coded catheter incorporates a passive, fully automatic safety needle shield, a multi-access blood control septum, an integrated stabilization platform and a Universal Back Cut Bevel tip. Together these features help protect clinicians from needlestick injuries, reduce blood exposure during insertion and connection changes, and improve catheter stability in the vein. The catheter provides double flashback (needle and catheter) for rapid visual confirmation of successful vein entry, and is indicated for short-term intravascular access for sampling blood, monitoring blood pressure and administering fluids or blood, as well as for compatible subcutaneous infusion and power injector applications. Each box contains 50 sterile, single-use, latex-, PVC- and DEHP-free catheters.
Bnefits
- Closed IV catheter design with multi-access blood control septum helps to reduce blood exposure during insertion and subsequent line changes.
- Passive, fully automatic safety needle shield activates without user action, helping to prevent needlestick injuries and cannot be bypassed.
- Polyurethane (PUR) catheter softens at body temperature, which is associated with improved comfort, longer indwell times and reduced phlebitis risk.
- Double flashback technology (needle and catheter flashback) provides fast visual confirmation that both the needle and catheter are correctly positioned in the vein, supporting first-stick success.
- Integrated stabilization platform is designed to minimize catheter movement within the vessel and help reduce catheter-related complications.
- Universal Back Cut Bevel tip geometry creates a flexible pathway for easier insertion into difficult veins with less tissue tearing.
- Multi-access septum allows multiple connections and disconnections (e.g. blood sampling, bolus doses, set changes) while controlling blood flow from the hub.
- Standard 18G (1.3 x 45 mm) size with green colour coding provides a high-flow option suitable for many adult infusion and transfusion applications.
- Latex-, PVC- and DEHP-free construction supports use in patients with sensitivities to these materials.
- Each catheter is individually sterile packaged and single-use, supporting infection prevention and consistent performance.
Indications
- Short-term peripheral intravascular access to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
- Use as a peripheral IV catheter for infusion therapy in hospital and clinical settings (e.g. wards, emergency departments, operating theatres, day units).
- Suitable for subcutaneous infusion therapies when used according to manufacturer instructions.
- Indicated for use with compatible power injectors (up to the specified pressure rating for Introcan Safety 3, typically up to 300–325 psi depending on gauge) for contrast media administration where allowed by local protocols.
- Intended for single-use only and for use by trained healthcare professionals in accordance with institutional policies and B. Braun’s instructions for use.
Composition
- Catheter: radiopaque polyurethane (PUR) that softens at body temperature.
- Needle: stainless steel over-the-needle introducer with Universal Back Cut Bevel tip design.
- Blood control system: integrated multi-access blood control septum within the catheter hub to limit blood backflow during needle withdrawal and subsequent Luer connections.
- Safety mechanism: passive, fully automatic needle-shielding clip that activates upon needle withdrawal and cannot be bypassed.
- Hub and stabilization: plastic catheter hub with integrated stabilization platform and raised Luer thread area.
- Flashback components: transparent flashback chamber and catheter shaft design providing double flashback (needle and catheter).
- Materials: latex-free, PVC-free, DEHP-free construction as specified for Introcan Safety 3.
Formulation
- Closed, over-the-needle peripheral IV catheter system with passive safety and blood control features.
- Gauge/size: 18G; external diameter approximately 1.3 mm; catheter length 45 mm; colour coding green.
- Luer connection: standard Luer lock compatible hub for connection to IV sets, extension lines and injection caps.
- Single-use, sterile device intended for short-term intravascular and subcutaneous access.
- Designed for multiple hub accesses via the blood control septum while maintaining flow control.
- Validated for use with power injectors up to the manufacturer-specified pressure rating for this gauge/length.
Packaging
- Each catheter unit is individually sterile blister or peel-packaged for single use.
- Box of 50 individually packaged Introcan Safety 3 PUR IV Catheters (18G x 45 mm, green).
- Outer box labelled with product name, gauge, size, colour code, lot number, expiry date, sterility information, and material information (latex-, PVC- and DEHP-free).
- Shipper cartons contain multiple boxes of 50 for bulk distribution to hospitals and healthcare facilities.
Usage
- Verify that the sterile packaging is intact and within the expiry date before use; do not use if the pack is damaged or expired.
- Prepare the insertion site using appropriate skin antisepsis according to local infection control policies.
- Open the sterile package and remove the catheter, holding it by the flashback chamber and wings, not by the catheter hub alone.
- Apply traction to the skin and insert the needle–catheter assembly into the vein at the recommended angle, observing for initial blood flashback in the needle flashback chamber.
- Once initial needle flashback is seen, advance slightly to confirm proper placement, then observe the second flashback within the catheter shaft (double flashback) to confirm that the catheter is also in the vein.
- Stabilise the catheter and vein, then advance the catheter into the vessel while maintaining needle position as recommended; once the catheter is fully advanced, withdraw the needle smoothly in a straight motion. The passive safety clip will automatically activate and cover the needle tip.
- Use vein occlusion technique as needed and observe the multi-access blood control septum limiting blood flow from the hub during needle removal and device connection.
- Attach the appropriate IV set, extension line or needle-free connector to the catheter hub Luer connection, ensuring it is fully seated and secure.
- Flush and secure the catheter in place with an appropriate sterile dressing and securement method, following manufacturer recommendations and institutional protocols.
- Monitor the insertion site regularly for signs of infiltration, phlebitis, infection or dislodgement, and remove the catheter if complications occur or when therapy is complete.
- Dispose of the used needle-containing safety device immediately into an approved sharps container; never attempt to recap or disable the safety mechanism.
- Do not reuse or resterilise; Introcan Safety 3 catheters are designed and validated for single use only.
Contraindications
- Do not use for patients with known hypersensitivity or allergy to polyurethane or other catheter materials if clinically relevant.
- Not intended for arterial cannulation or central venous access; use only for peripheral venous or indicated subcutaneous sites as per instructions.
- Do not insert through areas of active infection, inflammation, burns or compromised skin at the intended insertion site.
- Contraindicated in veins that are thrombosed, severely sclerosed or otherwise unsuitable for peripheral cannulation.
- Do not use if the sterility of the package is compromised, if components appear damaged or if there are visible manufacturing defects.
- Use with caution or alternative devices in patients where peripheral IV access is contraindicated by local clinical guidelines or the patient’s clinical condition.
Adverse Effects
- Local complications at the insertion site such as pain, bruising, hematoma, infiltration or extravasation.
- Phlebitis or thrombophlebitis, although the use of softening PUR material is intended to help reduce this risk.
- Infection at the insertion site or systemic infection (e.g., bloodstream infection) if aseptic technique and maintenance protocols are not strictly followed.
- Catheter occlusion or malfunction due to kinking, clot formation or precipitation of infused solutions.
- Allergic or hypersensitivity reactions to catheter materials in susceptible individuals.
- Air embolism or embolisation of clots or catheter fragments in rare cases of improper use or damage.
- Needlestick injury risk is significantly reduced but not entirely eliminated if the safety mechanism is impeded or the device is mishandled before activation.
Storage Conditions
- Store in the original packaging in a clean, dry environment at room temperature within the range specified on the box (typically 15–25°C), away from direct sunlight and moisture.
- Avoid exposure to excessive heat, cold or humidity that could compromise packaging integrity or material performance.
- Do not store near solvents, chemicals or gases that may degrade plastic materials or packaging.
- Keep out of reach of children and unauthorised persons, and separate from non-sterile items to maintain sterility until use.
Duration
Designed for short-term peripheral IV use; actual dwell time depends on clinical indication, vein condition, catheter site and institutional policies, with regular reassessment for ongoing need and site integrity.
Onset
Not applicable \u2013 this is a mechanical vascular access device; onset and duration of clinical effect depend on the fluids or medications infused through the catheter.
