BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter 20 22G x 1\ (25 mm) with Blood Control Technology
Becton Dickinson
Medical device – peripheral IV catheterSafety peripheral IV catheter with push-button needle retraction and blood control technology
Certifications
- CE Marked medical device (CE mark with notified body number 2797) under the European Medical Devices Directive / Regulation and recognised under corresponding UK medical device requirements.
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Designed and tested in accordance with applicable ISO and EN standards for intravascular catheters and needle Based safety Engineered devices.
- Sterilisation validated to an accepted sterility assurance level in accordance with ISO standards for terminally sterilised medical devices.
- Biocompatibility of materials evaluated in line with ISO 10993 series requirements for devices with blood and tissue contact.
- Latex Free and DEHP Free status consistent with BD labelling and regulatory guidance for minimising exposure to sensitising and plasticiser substances.
- CE Marked medical device (CE mark with notified body number 2797) under the European Medical Devices Directive / Regulation and recognised under corresponding UK medical device requirements.
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Designed and tested in accordance with applicable ISO and EN standards for intravascular catheters and needle Based safety Engineered devices.
- Sterilisation validated to an accepted sterility assurance level in accordance with ISO standards for terminally sterilised medical devices.
- Biocompatibility of materials evaluated in line with ISO 10993 series requirements for devices with blood and tissue contact.
- Latex Free and DEHP Free status consistent with BD labelling and regulatory guidance for minimising exposure to sensitising and plasticiser substances.
Safety peripheral IV catheter with push-button needle retraction and blood control technology
Description
The BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter 22G x 1\ (25 mm) is a sterile, single-use, over-the-needle peripheral IV catheter designed for intravascular access and the administration of fluids, medications and blood products. It combines BD’s push-button Autoguard™ safety mechanism with integrated Blood Control Technology and BD Vialon™ catheter material. With the push of a button, the needle instantly retracts into a safety barrel, helping to reduce the risk of accidental needlestick injuries. Blood Control Technology helps stop blood flowing from the catheter hub after venepuncture, reducing blood exposure, mess and the need for digital pressure while making the initial Luer connection. The radiopaque BD Vialon™ catheter softens in the vein, supporting longer dwell times and lowering the risk of mechanical phlebitis compared with traditional FEP catheters. BD Instaflash™ needle technology (on 18–24 G sizes) provides immediate visual confirmation of vessel entry to support first-attempt success. The 22G x 1\ BC Pro variant (REF 381023) is a non-winged, blue-coded catheter supplied in boxes of 50 for hospital and clinical use.
Bnefits
- Integrated Blood Control Technology helps stop blood at the catheter hub until the initial Luer connection is made, reducing blood leakage and healthcare worker blood exposure.
- Push-button Autoguard™ safety mechanism instantly retracts and encases the needle in a safety barrel, helping to reduce the risk of accidental needlestick injuries.
- BD Vialon™ catheter material softens in the vein (up to approximately 70%), enabling longer dwell times and reducing the incidence of mechanical phlebitis compared with FEP catheters.
- BD Instaflash™ needle technology (on 18–24 G catheters) provides rapid flashback at the needle tip and along the catheter, helping to confirm vessel entry and improve first-stick success.
- BC Pro design with taller push tab and three-ridge grip is engineered to give clinicians better control during catheter insertion and advancement.
- Reduces the need to apply digital pressure at the insertion site during needle withdrawal, minimising vein compression and procedural disruption.
- Helps maintain a cleaner insertion field with less blood spillage, which can improve workflow efficiency and patient confidence.
- Compatible with power injectors up to a maximum pressure of 300 psi (for 22–18 G sizes) when used in accordance with manufacturer instructions for high-pressure injection.
- Radiopaque catheter body facilitates visualisation on X-ray, supporting confirmation of catheter position when required.
- Latex-free and DEHP-free design reduces the risk of latex-related and phthalate-related sensitivities.
- Available in a standardised 22G x 1" (0.9 mm x 25 mm) size with blue colour coding, supporting consistent catheter selection in clinical practice.
Indications
- Peripheral intravenous (IV) cannulation for the administration of IV fluids, medications, blood and blood components where a 22G peripheral IV catheter is clinically appropriate.
- Short-term peripheral vascular access in adult and paediatric patients, according to institutional protocols and clinician judgement.
- Clinical situations where integrated needle safety and blood control features are desired to reduce needlestick injury risk and blood exposure to healthcare workers.
- Use in general medical, surgical, emergency, outpatient, diagnostic and day-case settings requiring routine peripheral IV access.
Composition
- Catheter: BD Vialon™ radiopaque polyurethane biomaterial, colour coded blue for 22G.
- Needle cannula: Stainless steel hypodermic tubing with bevelled tip and Instaflash™ notch for rapid flashback (on 18–24G sizes).
- Needle hub and housing: Medical-grade polymer components forming the push-button Autoguard™ safety barrel and grip.
- Blood control element: Internal blood control valve/plug integrated in the catheter hub to limit blood flow prior to Luer connection.
- Flash chamber: Transparent polymer chamber with vent plug to visualise blood return and enable pressure equalisation.
- Catheter hub: Transparent or translucent polymer hub with standard Luer connection, colour coded for gauge.
- Button and push tab: Moulded polymer components forming the Autoguard™ push-button and BC Pro taller push tab with three ridges.
- Lubricants: Medical-grade silicone-based lubricant on needle/catheter interfaces to allow smooth catheter advancement and needle retraction.
- Radiopacifier: Barium sulfate or equivalent radiopaque filler incorporated within BD Vialon™ catheter material.
- Latex status: Device is latex-free; natural rubber latex is not intentionally used in the product materials or packaging.
- Plastic materials used in fluid path and device structure are DEHP-free in accordance with BD product labelling for this line.
Formulation
- Device type: Over-the-needle, non-winged, shielded peripheral IV catheter with integrated blood control technology and push-button needle retraction.
- Gauge and length: 22 gauge (approx. 0.9 mm outer diameter) x 1.00 inch (25 mm) catheter.
- Reference / catalogue number: 381023 (BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter 22 G x 1.00 in.).
- Colour coding: Blue hub and/or components indicative of 22G size according to ISO colour standards for IV catheters.
- Blood control: Internal valve mechanism designed to stop or significantly reduce blood flow from the hub until connection to an infusion device.
- Safety mechanism: Autoguard™ push-button safety barrel that retracts and locks the needle after use.
- Catheter material: BD Vialon™ polyurethane biomaterial, radiopaque, softening in vivo.
- Flow characteristics: Typical gravity flow rate for 22G length 1" approximately in the mid-30 mL/min range for standard IV fluids (exact values per BD technical literature).
- Pressure rating: Suitable for use with power injectors up to a maximum of 300 psi (2068 kPa) for 22–18 G devices when used according to manufacturer power injection guidance.
- Sterilisation: Sterile, single-use device sterilised by an appropriate validated method (e.g., ethylene oxide) to an accepted sterility assurance level.
- Regulatory classification: CE-marked peripheral IV catheter (EU Class IIa / UK equivalent) under medical device regulations.
Packaging
- Primary packaging: Individual sterile blister pack/pouch containing one BD Insyte™ Autoguard™ BC Pro 22G x 1" catheter, needle and safety mechanism.
- Pack size (Medisave listing): Box of 50 individually packaged, single-use catheters.
- Shelf pack / case: Higher-level cartons or cases may contain multiple boxes (e.g., 4 boxes per case) depending on regional distribution configuration.
- Labelling: Each unit and outer pack labelled with product name, gauge and length (22G x 1"), BD logo, REF 381023, lot number, expiry date, sterilisation method, single-use symbol, CE mark and relevant regulatory symbols.
- Protection: Packaging designed to maintain sterility and protect the catheter and needle from mechanical damage, moisture and contamination during shipping and storage.
Usage
- Verify the integrity of the sterile package and check the expiry date; do not use if the package is damaged, opened or expired.
- Perform hand hygiene and don appropriate personal protective equipment according to institutional protocol.
- Select an appropriate peripheral vein and site for cannulation, taking into account vein size, therapy type and expected dwell time.
- Prepare the skin with an appropriate antiseptic agent and allow it to dry as per local infection prevention guidelines.
- Open the sterile package and remove the catheter device aseptically, taking care not to contaminate the catheter or needle.
- Stabilise the chosen vein and insert the catheter/needle assembly bevel up at the recommended angle to the skin, advancing until blood flashback is observed in the flash chamber and/or along the Instaflash™ window.
- Lower the angle and advance the catheter slightly to ensure the catheter tip is within the vessel lumen while avoiding over-insertion.
- Holding the catheter steady, press the Autoguard™ push button to retract the needle into the safety barrel; the needle will lock in the shielded position, reducing needlestick injury risk.
- Advance the catheter fully into the vein as appropriate while maintaining vein stabilisation; Blood Control Technology will limit blood flow from the hub without the need for digital pressure at the insertion site.
- Connect the catheter hub to the prepared IV line, extension set or compatible Luer device, ensuring a secure Luer lock connection is made promptly to re-establish fluid path and prevent blood leakage.
- Flush the catheter and confirm patency and correct intravascular placement according to institutional protocol (e.g., by observing for easy flush and absence of swelling or pain).
- Secure the catheter with an appropriate sterile dressing and fixation device, labelling with date/time and other required information.
- Monitor the site regularly for signs of infiltration, phlebitis, infection or dislodgement and replace the catheter according to clinical condition and institutional policies.
- After use or when the catheter is removed, dispose of the entire device (with needle permanently shielded) in an approved sharps container; do not attempt to defeat the safety mechanism, recap or reuse.
Contraindications
- Do not use in patients with known hypersensitivity or allergy to polyurethane (BD Vialon™), stainless steel or any other component of the device if such sensitivity has been clinically established.
- Not intended for arterial, intra-cardiac, spinal or epidural use; the device is designed for peripheral venous access only.
- Do not use if the packaging is open, damaged or otherwise compromised, or if the product is past the labelled expiry date.
- Do not reinsert the needle into the catheter once it has been partially or fully withdrawn, as this may shear the catheter and pose a risk of catheter embolism.
- Do not reuse, reprocess or resterilise the catheter; reuse may lead to infection, device malfunction or compromised safety performance.
- Avoid use in sites with signs of infection, phlebitis, thrombosis, burn injury or compromised skin integrity unless no alternative sites are available and risks are justified.
- Use with high-pressure power injectors only within the specified gauge, length and maximum pressure limits recommended by BD; exceeding these limits may lead to catheter failure or vessel injury.
Adverse Effects
- Local complications at the insertion site such as pain, erythema, tenderness, swelling, haematoma or bruising.
- Mechanical or chemical phlebitis, presenting as warmth, pain, redness and a palpable cord along the vein.
- Infiltration or extravasation of fluids or medications into surrounding tissues, potentially causing local tissue injury depending on the infusate.
- Catheter-related infection or local cellulitis if aseptic technique is not followed or if the catheter is left in situ beyond recommended dwell time.
- Very rare risk of catheter fragment embolisation if improper attempts are made to reinsert the needle into a partially advanced catheter.
- Air embolism, thrombosis or embolic events if the device is improperly handled or if lines are not adequately de-aired and secured.
- Systemic reactions or complications related to infused drugs (e.g., allergic reactions, fluid overload), which are attributable to the therapy rather than the catheter itself.
- Needlestick injuries are significantly reduced by the safety design but may still occur if the device is misused or safety procedures are not followed.
Storage Conditions
- Store in original packaging in a clean, dry environment.
- Maintain at normal room temperature conditions within the range specified on the product labelling; avoid extremes of heat and freezing.
- Protect from excessive moisture, direct sunlight and mechanical stress that could damage packaging or device components.
- Do not use the product after the expiration date printed on the packaging.
- Keep out of reach of children and unauthorised personnel.
- Store away from sources of contamination and chemicals that could compromise packaging integrity.
Duration
Single-use peripheral IV catheter intended for one patient; dwell time is determined by clinical need, vein condition and institutional policy. BD Vialon\u2122 material is designed to support longer dwell times compared with FEP catheters, but catheters should be assessed frequently and replaced according to local guidelines (often 72\u201396 hours or as clinically indicated).
Onset
Not directly applicable to the device; onset and duration of therapeutic effect depend on the drugs or fluids infused and the clinical context rather than the catheter itself.
