BD Nexiva™ Closed IV Catheter System

Becton Dickinson

Medical device – peripheral intravenous catheter system

Closed IV catheter system, dual-port, 20G with integrated extension set and needle-free connectors

CE Marked medical device (classification dependent on regional regulations) for peripheral intravenous use.
Manufactured under an ISO 13485 Compliant quality management system for medical devices.
Conforms to relevant standards for intravascular catheters and luer connections (including applicable parts of ISO 10555 and ISO 80369, as regionally required).
Sterile, non Pyrogenic, single Use device produced in accordance with recognised infusion therapy and infection prevention standards.

CE Marked medical device (classification dependent on regional regulations) for peripheral intravenous use.
Manufactured under an ISO 13485 Compliant quality management system for medical devices.
Conforms to relevant standards for intravascular catheters and luer connections (including applicable parts of ISO 10555 and ISO 80369, as regionally required).
Sterile, non Pyrogenic, single Use device produced in accordance with recognised infusion therapy and infection prevention standards.

Closed IV catheter system, dual-port, 20G with integrated extension set and needle-free connectors

Description

The BD Nexiva™ Closed IV Catheter System (20G x 1.25 in., 1.1 mm x 32 mm) with dual ports and BD Q-Syte™ needle-free connectors is an integrated, all-in-one peripheral intravenous catheter system designed to reduce the risk of IV catheter failure and blood exposure. This closed system combines a BD Vialon™ biomaterial catheter, pre-attached extension set, built-in stabilization platform and two BD Q-Syte™ needle-free connectors into a single device. The 20-gauge catheter incorporates blood control technology to help contain blood during insertion, while BD Vialon™ softens in the vessel to support longer dwell times and reduce mechanical phlebitis. The dual-port configuration allows simultaneous administration of compatible solutions close to the insertion site, improving workflow and reducing the need for additional access devices. Each unit is sterile, non-pyrogenic and intended for single use, supplied in a box of 20 with a case configuration of 80.

Bnefits

Closed, all-in-one IV catheter system that integrates catheter, extension set, stabilization platform and needle-free connectors, reducing the need for multiple separate components.
Dual-port configuration with two BD Q-Syte™ needle-free connectors enables simultaneous administration of compatible fluids and medications near the insertion site.
Closed single-lumen fluid path designed to contain blood during insertion, reducing blood exposure and the potential for contamination at connections.
Catheter manufactured from BD Vialon™ biomaterial, which softens in the vessel to improve comfort, support longer dwell times and help reduce mechanical phlebitis.
Built-in stabilization platform minimises catheter movement in the vessel, reducing dislodgement, irritation and catheter-related complications.
Blood control technology (blood control: Yes in product specification) helps limit blood leakage at insertion and improves insertion-site cleanliness.
20G x 1.25 in. catheter size (1.1 mm x 32 mm) offers a balance of flow rate (approx. 58 mL/min by gravity) and patient comfort for a wide range of IV therapies.
High pressure rating (up to 300 psi) suitable for power injection of contrast media when used according to manufacturer instructions.
Pink hub colour supports fast visual identification of 20G size in busy clinical settings.
Supplied sterile and single use to support infection prevention and adherence to infusion therapy standards.

Indications

Peripheral intravenous cannulation for short- to medium-term administration of IV fluids, medications and blood products using a closed IV catheter system.
Clinical situations where reduction of blood exposure and contamination risk is a priority, such as emergency departments, intensive care, oncology and surgical wards.
Patients requiring simultaneous administration of two compatible solutions via a dual-port peripheral IV catheter.
Use in adult and appropriate paediatric patients where a 20G x 1.25 in. peripheral IV catheter is clinically indicated.
Settings where longer catheter dwell times and reduced catheter-related complications are desired compared with open IV systems.

Composition

Catheter: BD Vialon™ polyurethane biomaterial, 20G (approx. 1.1 mm outer diameter) x 1.25 in. (32 mm) length.
Introducer needle: stainless steel IV needle with bevelled tip and integrated blood control features.
Extension set: pre-attached single-lumen extension tubing with integrated clamp, forming a closed fluid path from catheter hub to connectors.
Needle-free connectors: two BD Q-Syte™ luer access split-septum needle-free connectors for dual-port access.
Stabilization platform: soft, integrated catheter stabilization platform designed for secure fixation and patient comfort.
Hub and housings: medical-grade polymer components, pink-coloured catheter hub to indicate 20G size.
Sterilization: ethylene oxide (ETO) sterilized, non-pyrogenic, single-use device.

Formulation

Closed peripheral IV catheter system comprising a 20G x 1.25 in. BD Vialon™ catheter, stainless steel introducer needle, integrated extension set with clamp, built-in stabilization platform and two BD Q-Syte™ luer access needle-free connectors, sterile and single use.

Packaging

Individual units packaged in sterile, peel-open blisters or pouches containing a single BD Nexiva™ Closed IV Catheter System (20G x 1.25 in., dual-port with BD Q-Syte™ connectors).
Box (shelfpack) quantity: 20 devices per box, as specified by BD product data for SKU 383537.
Case quantity: 80 devices per case (typically 4 shelfpacks of 20).
Outer carton and unit packaging labelled with product name, gauge and length (20G x 1.25 in.), SKU 383537, GTIN codes, lot number, expiry date, sterilization method and regulatory marks (including CE where applicable).

Usage

Verify the product (BD Nexiva™ Closed IV Catheter System, 20G x 1.25 in., dual-port) is appropriate for the patient and intended therapy before use.
Check the packaging for integrity and confirm that the product is within its expiry date; do not use if packaging is damaged or expired.
Prepare the patient and insertion site following aseptic technique and institutional infusion therapy guidelines.
Remove the device from its sterile package, maintaining sterility of the catheter, needle and connectors.
Ensure clamps on the extension set are in the correct position and prime the extension tubing and BD Q-Syte™ connectors with compatible fluid if required by protocol, avoiding introduction of air.
Stabilise the selected vein and insert the catheter/needle assembly with the bevel up at the appropriate angle, observing for immediate blood flashback in the closed system to confirm vessel entry.
Advance the BD Vialon™ catheter into the vessel while withdrawing the introducer needle according to manufacturer instructions; do not reinsert the needle into the catheter once withdrawn.
Secure the integrated stabilization platform to the skin using an appropriate securement dressing and fixation method, ensuring the catheter is well supported.
Connect IV administration sets or syringes to the BD Q-Syte™ needle-free connectors using standard luer-lock technique, disinfecting the connector septum prior to each access in accordance with infection prevention policies.
Routinely assess the insertion site and catheter function for signs of infiltration, phlebitis, occlusion or infection, and replace the catheter per institutional dwell-time policies or if complications are observed.
Upon completion of therapy or if removal is indicated, clamp the extension set, disconnect lines and carefully withdraw the catheter, applying pressure to the site as required, then dispose of the entire device in an approved sharps/clinical waste container. Do not reuse.

Contraindications

Do not use in patients with known hypersensitivity or allergy to any component of the device (e.g. polyurethane, stainless steel, or other materials).
Not intended for arterial cannulation, central venous access or any application not consistent with peripheral IV catheter use.
Avoid insertion into limbs or sites with significant infection, burns, thrombosis, oedema or compromised circulation unless clinically justified.
Do not reuse; reuse of this single-use device may increase the risk of infection, catheter malfunction or device failure.
Do not reinsert the introducer needle into the catheter after withdrawal, as this may damage the catheter and pose risk of embolisation or failure.

Adverse Effects

Local reactions at the insertion site such as pain, redness, swelling, bruising or bleeding.
Infiltration or extravasation of infusate into surrounding tissue, potentially causing swelling or tissue injury.
Phlebitis or thrombophlebitis, particularly with prolonged dwell time or inadequate site care.
Catheter-related bloodstream infection if aseptic technique and maintenance protocols are not strictly followed.
Catheter occlusion or malfunction requiring replacement of the device.
Rare risk of catheter breakage, embolisation or air embolism if the device is misused or infusion practices are inadequate.

Storage Conditions

Store in a clean, dry environment at controlled room temperature, away from excessive heat, cold and direct sunlight.
Keep product in its original packaging until point of use to maintain sterility.
Do not use if primary packaging is torn, wet, punctured or otherwise compromised.
Do not use beyond the expiry date indicated on the packaging.
Protect from crushing, bending or other physical damage that could affect device integrity or performance.
Store out of reach of unauthorised persons and children.