Caresite Luer Access Device
Caresite
Injection & InfusionNeedleless IV luer access connector (positive displacement)
Certifications
- Class IIb sterile, single Use medical device in the EU/UK under relevant Medical Device legislation (B. Braun Caresite family).
- Not made with natural rubber latex.
- Not made with DEHP (as per B. Braun Caresite needleless connector product information).
- FDA 510(k) cleared in the United States as a needleless connector for IV therapy (e.g. K140311).
- Manufactured under an ISO 13485 Compliant quality management system.
- Power Injection capable up to 400 psi and 15 mL/sec for the straight valve configuration.
- Class IIb sterile, single Use medical device in the EU/UK under relevant Medical Device legislation (B. Braun Caresite family).
- Not made with natural rubber latex.
- Not made with DEHP (as per B. Braun Caresite needleless connector product information).
- FDA 510(k) cleared in the United States as a needleless connector for IV therapy (e.g. K140311).
- Manufactured under an ISO 13485 Compliant quality management system.
- Power Injection capable up to 400 psi and 15 mL/sec for the straight valve configuration.
Needleless IV luer access connector (positive displacement)
Description
The Caresite Luer Access Device is a needle-free, luer-activated, closed-system connector with a positive displacement feature, designed by B. Braun for intravenous infusion and transfusion therapies. Upon insertion of a male luer fitting (luer slip or luer lock), the split-septum valve opens to allow aspiration, injection or gravity/pump flow of IV fluids and blood. When the male luer is disconnected, the valve’s positive displacement action helps push a small bolus of fluid into the catheter lumen, reducing blood reflux and the risk of catheter occlusion. The clear housing and open fluid path allow visual confirmation of flushing and minimise fluid entrapment areas, while the smooth, flat access surface is easy to disinfect. The device forms a closed system intended to limit microbial ingress and contamination, protect healthcare workers from accidental needlestick injuries and support efficient IV therapy. Each Medisave sales unit contains 100 sterile Caresite Luer Access Devices.
Bnefits
- Needleless luer access connector that helps protect healthcare workers from accidental needlestick injuries.
- Positive displacement feature reduces the risk of catheter occlusions by limiting blood reflux when the luer is disconnected.
- Closed system design intended to prevent microbial ingress and minimise escape of contaminants.
- Luer-activated split-septum valve allows aspiration, injection or gravity/pump infusion upon insertion of a male luer connector.
- Compatible with both luer slip and luer lock connectors, including syringes and IV tubing sets.
- Clear outer housing and open fluid path allow easy visual inspection and verification of proper flushing.
- Smooth, flat access surface is easy to clean and disinfect with standard antiseptics (including alcohol when used per IFU).
- High-pressure resistant and power-injection rated (up to 400 psi and 15 mL/sec for the straight valve configuration), providing flexibility for a range of IV procedures.
- Low priming and retained volumes help reduce drug and blood wastage.
- Durable design tested to support multiple connections (up to 1000 accesses in performance data for straight valve), improving efficiency and line longevity.
Indications
- Needleless IV infusion and transfusion therapy requiring aspiration, injection or gravity/pump flow of IV fluids and blood.
- Use as a luer access point on peripheral or central venous catheters, extension sets and IV lines in adult, paediatric or neonatal patients as clinically appropriate.
- Reduction of needlestick injury risk by replacing traditional injection ports that require needles.
- Reduction of catheter occlusion risk through positive displacement flushing behaviour.
Composition
- Needle-free, luer-activated split-septum valve mechanism housed within a clear polymer body.
- Clear outer housing (medical-grade plastic) providing visibility of the internal fluid path and flush.
- Elastomeric septum components designed for repeated luer access and reliable resealing.
- Not made with natural rubber latex.
- Not made with DEHP (per B. Braun product information for Caresite needleless connectors).
- Materials compatible with blood, lipids and commonly used IV solutions when used according to the instructions for use.
Formulation
- Sterile, single-use medical device (no active pharmaceutical ingredient).
- Needle-free luer access connector with positive displacement and split-septum valve.
- Priming volume (straight valve configuration): approximately 0.22 mL.
- Retained volume (straight valve configuration): approximately 0.20 mL.
- Pressure resistance: rated up to 400 psi at 15 mL/sec for power injection (straight valve configuration, per product data and FDA summary).
Packaging
- Box of 100 sterile Caresite Luer Access Devices (Medisave listing: x 100).
- Each device supplied sterile in peel-pouch packaging for aseptic handling.
- Outer carton labelled with product name, brand (B. Braun Caresite), SKU/REF 415122-01, quantity, lot number, expiry date and sterilisation method.
- Additional packaging configurations (e.g. individual pieces vs boxes of 100) available through other distributors but Medisave product context is 100 per box.
Usage
- Inspect the sterile peel pouch before use. Do not use if the pouch is damaged, opened or past the expiry date.
- Using aseptic technique, open the peel pouch and remove the Caresite Luer Access Device, taking care not to touch the connection surfaces.
- Attach the device to the catheter hub, extension set or IV line using the female luer connection, ensuring a secure fit as per institutional protocol.
- Before each access, disinfect the smooth, flat access surface according to local infection-prevention guidelines (e.g. scrub with an appropriate disinfectant such as 70% alcohol for the recommended contact time) and allow to dry.
- To access the device, attach a sterile luer slip or luer lock syringe or IV set directly to the valve by pushing straight and, if applicable, twisting to lock (luer lock). Avoid excessive angulation to prevent damage.
- Administer the prescribed infusion, injection or aspiration as required. The positive displacement mechanism will aid in flushing the catheter lumen upon disconnection.
- After use, disconnect the luer device, ensuring that any residual pressure is managed according to local protocol. Do not leave luer slip syringes unattended while connected.
- Disinfect the access surface again after use if the device remains in place for further accesses.
- Replace the Caresite Luer Access Device according to hospital policy, manufacturer recommendations or if contamination, damage or malfunction is suspected.
- Dispose of used devices as clinical waste in accordance with local regulations.
Contraindications
- Do not use in patients with known hypersensitivity to device materials if clinically relevant (e.g. known allergy to specific plastics or elastomers), unless assessed and approved by a clinician.
- Not intended for use as an arterial line connector unless specifically allowed by local protocol and manufacturer guidance.
- Do not use if the sterile packaging is damaged, opened or expired.
- Do not use with incompatible fluids or drugs where the compatibility with device materials has not been established.
- Do not re-sterilise or reuse; the Caresite Luer Access Device is intended for single-patient use according to the manufacturer’s instructions.
Adverse Effects
- Potential for catheter-related bloodstream infection if aseptic technique and proper disinfection of the access surface are not maintained.
- Possible device-related occlusion or flow issues if the connector is damaged, contaminated or improperly flushed.
- Local site complications (e.g. phlebitis, infiltration, extravasation) related to the underlying IV therapy rather than the connector itself.
- Rare risk of air embolism if lines are not properly primed or if disconnection/reconnection steps are not performed according to protocol.
- Allergic reactions to device materials are theoretically possible but uncommon.
Storage Conditions
- Store in a clean, dry environment at room temperature, away from direct sunlight and excessive heat or cold.
- Keep in original packaging until time of use to maintain sterility and protect from physical damage.
- Do not expose the pouches to sharp objects or crushing that could compromise sterility.
- Observe the expiry date printed on the packaging and do not use beyond this date.
