$CARESITE Needleless Connector, 8\ Bonded High Pressure Small Bore Extension Set$

CARESITE Needleless Connector, 8\ Bonded High Pressure Small Bore Extension Set

Caresite

Injection & Infusion

Positive displacement needleless connector with bonded high pressure small bore extension set

Class IIb sterile single Use medical device under applicable EU/UK medical device regulations (B. Braun CARESITE family).
Not made with natural rubber latex.
Not made with DEHP.
Manufactured under an ISO 13485 Compliant quality management system.
Power injection rated up to 300 psi and 10 mL/sec when used according to manufacturer instructions.

Class IIb sterile single Use medical device under applicable EU/UK medical device regulations (B. Braun CARESITE family).
Not made with natural rubber latex.
Not made with DEHP.
Manufactured under an ISO 13485 Compliant quality management system.
Power injection rated up to 300 psi and 10 mL/sec when used according to manufacturer instructions.

Positive displacement needleless connector with bonded high pressure small bore extension set

Description

The CARESITE Needleless Connector, 8\ Bonded High Pressure Small Bore Extension Set is a sterile, single-use, positive displacement needleless IV connector with an integrated 8\ (20 cm) high pressure small bore extension line. It features a clear housing and luer-activated valve that opens on connection of a male luer fitting to allow aspiration, injection or gravity/pump flow of IV fluids and blood. The bonded small bore extension set includes a non-removable slide clamp and rotating spin-lock male luer lock. The set is not made with DEHP and not made with natural rubber latex, has a priming volume of 0.5 mL, and is power injection rated up to 300 psi with a maximum flow rate of 10 mL/sec, making it suitable for high-pressure infusion applications as well as routine IV therapy.

Bnefits

Positive displacement needleless connector helps reduce blood reflux into the catheter lumen and thereby lowers the risk of catheter occlusions.
Needle-free luer access protects healthcare workers from accidental needlestick injuries compared with traditional needle-based ports.
Clear housing and open fluid path allow visual inspection of fluid flow and confirmation of complete flushing.
High pressure bonded 8" (20 cm) small bore extension set rated to 300 psi and 10 mL/sec enables compatibility with power injection and high-pressure infusions (as per manufacturer instructions).
Non-removable slide clamp allows secure line occlusion when required, helping prevent inadvertent flow.
Rotating spin-lock male luer lock provides a secure connection to catheters and other IV components while reducing tubing torsion.
Not made with DEHP and not made with natural rubber latex, reducing exposure to these materials for patients and staff.
Low priming volume of 0.5 mL minimises drug dilution and wastage, especially important for potent medications.
Designed as part of B. Braun’s CARESITE closed-system needleless connector range to support infection prevention and efficient IV therapy.

Indications

Needleless luer access for intravenous infusion and transfusion therapy, including aspiration, injection and gravity or pump-controlled flow of IV fluids and blood.
Use as an extension and access point on peripheral and central venous catheters in adult, paediatric and neonatal patients where clinically appropriate.
Applications where positive displacement needleless connectors are preferred to help reduce catheter occlusions and improve line patency.
Situations requiring high-pressure injection (up to 300 psi and 10 mL/sec) in accordance with manufacturer and institutional protocols.

Composition

Clear medical-grade polymer housing for the needleless connector.
Internal elastomeric split-septum / valve components designed for repeated luer access and resealing.
Small bore extension tubing (PVC-based, contains PVC as per distributor specifications).
Integrated non-removable slide clamp constructed of medical-grade plastic.
Rotating spin-lock male luer lock connector (medical-grade polymer).
Not made with natural rubber latex.
Not made with DEHP.
Contains BPA and PVC (per specifications from some distributors).

Formulation

Sterile, single-use medical device (no active pharmaceutical ingredient).
Positive displacement needleless connector with bonded high pressure small bore extension set.
Priming volume: 0.5 mL.
Pressure rating: up to 300 psi.
Maximum flow rate: 10 mL/sec.
Length of bonded extension: 8" (20 cm).

Packaging

Case/box of 100 CARESITE Needleless Connector, 8" Bonded High Pressure Small Bore Extension Sets.
Each set is individually packaged in a sterile peel pouch for aseptic presentation.
Outer carton labelled with product name, brand (B. Braun CARESITE), product code (470100), quantity (100), lot number, and expiry date.
Packaging clearly indicates that the set is sterile, latex-free and DEHP-free.

Usage

Before use, inspect the outer carton and individual sterile pouches. Do not use if packaging is damaged, opened, or past the expiry date.
Open the sterile peel pouch using aseptic technique and remove the CARESITE extension set without contaminating the connection surfaces.
Attach the rotating spin-lock male luer lock of the extension set to the appropriate catheter hub or IV access device, tightening to ensure a secure, leak-free connection.
Ensure the slide clamp on the extension set is in the closed position before priming to control flow.
Prime the extension set and CARESITE connector with compatible IV fluid according to institutional protocol, removing air from the system. The priming volume is approximately 0.5 mL.
Disinfect the flat access surface of the needleless connector with an appropriate antiseptic (e.g. 70% alcohol or other facility-approved agent) for the recommended scrub time and allow to dry completely before each access.
Connect a sterile luer slip or luer lock syringe or IV line by pushing straight onto the valve (and twisting if using luer lock) to open the connector for aspiration, injection or infusion.
After administering therapy, disconnect the luer device according to protocol. The positive displacement mechanism will help flush a small volume into the catheter, reducing blood reflux.
If the extension set remains in situ, clamp and disinfect the access surface again as per local infection prevention guidelines.
Replace the extension set and connector according to hospital policy, manufacturer recommendations, or if contamination, damage or malfunction is suspected.
Dispose of used sets as clinical waste in accordance with local regulations. Do not attempt to re-sterilise or reuse.

Contraindications

Do not use in patients with known hypersensitivity to any component materials (e.g. specific plastics or elastomers) if clinically relevant.
Not intended for arterial lines or applications outside the pressure and flow ratings unless explicitly permitted by manufacturer guidance and local protocols.
Do not use if sterile packaging is damaged, opened prematurely, or if the product is past its labelled expiry date.
Do not re-sterilise or reuse; single-patient, single-use device only.

Adverse Effects

Potential catheter-related bloodstream infection if proper aseptic technique and disinfection of the access surface are not followed.
Possible occlusion or impaired flow if the connector or extension tubing becomes kinked, clamped, damaged or improperly flushed.
Local site complications such as phlebitis, infiltration or extravasation related to the underlying IV therapy rather than the connector itself.
Rare risk of air embolism if lines are not properly primed or are mishandled during connection/disconnection.
Very rare allergic or hypersensitivity reactions to device materials.

Storage Conditions

Store in a clean, dry area at ambient room temperature, away from direct sunlight and extremes of heat or cold.
Keep products in their original cartons until point of use to protect from physical damage and contamination.
Avoid crushing or bending the packaged sets, which could damage the tubing or connectors.
Do not use beyond the expiry date printed on the packaging.