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Bionector Single Lumen Extension Set 10cm

Bionector Single Lumen Extension Set 10cm

Vygon

Injection & Infusion
  • CE Marked medical device under applicable European Medical Device Directives/Regulations.
  • Manufactured under an ISO 13485 Compliant quality management system for medical devices (Vygon).
  • Latex Free, PVC Free and DEHP Free as stated for Bionector Octopus extension products.
  • Non Pyrogenic and supplied sterile for single use only.
  • Designed and tested for compatibility with standard IV infusion therapy practices and disinfection procedures for needle Free connectors.
Single lumen PUR IV extension line with needle-free connector

Description

The Bionector Single Lumen Extension Set 10cm is a sterile, single-use polyurethane (PUR) extension line with an integrated, latex-free Bionector needle-free connector and clamp. Designed mainly for use with peripheral IV catheters, this short 10 cm extension provides a flexible, transparent, low dead-space line that allows intermittent injections, continuous infusions and blood sampling through a closed, disinfectable access port. The integrated flat clamp enables secure flow control, while the PUR tubing is PVC- and DEHP-free for improved biocompatibility and to reduce the risk of drug interactions and plasticiser leaching. The rotating male luer-lock collar allows secure, low-torque connection to the catheter hub, helping reduce catheter movement and mechanical phlebitis. It is suitable for hospital and clinical use wherever a short, needle-free IV extension is required.

Bnefits

  • Single lumen PUR extension line with integrated Bionector needle-free connector and clamp for safe, closed IV access.
  • Supports intermittent injections, continuous infusions and blood sampling without using non-disinfectable injection ports or needles.
  • Needle-free access helps eliminate the risk of access-related needlestick injury for staff.
  • Closed, disinfectable system reduces the risk of blood reflux, contamination and catheter-related infection when used correctly.
  • PUR tubing is transparent, flexible, PVC-free and DEHP-free, improving biocompatibility and reducing drug interaction and plasticiser leaching risk.
  • Low dead-space design helps minimise drug loss and promotes accurate dosing of critical medications.
  • Rotating male luer-lock collar enables easier, more secure connection to peripheral IV catheters, reducing catheter movement and mechanical vein irritation.
  • Flat clamp on the line permits simple, reliable flow control and line isolation.
  • Latex-free construction reduces risk of latex allergy reactions for patients and staff.
  • Supplied sterile and single-use, supporting good infection prevention and control practice.

Indications

  • Use as a single-lumen IV extension tube attached to a peripheral or central IV catheter hub to provide needle-free access.
  • Situations requiring a short 10 cm extension line to move connection points away from the catheter site and facilitate line management.
  • Clinical settings where needle-free, closed IV access is needed to reduce needlestick injury risk and improve infection control.
  • Infusion therapy requiring low dead-space, biocompatible tubing (e.g., for potent or expensive drugs where drug loss should be minimised).
  • Peripheral cannula care in hospital wards, critical care, theatres and outpatient areas as per local protocols.

Composition

  • Tubing material: medical-grade polyurethane (PUR), transparent and flexible.
  • Lumen: single internal fluid pathway (single lumen).
  • Length: 10 cm extension tube.
  • Needle-free connector: integrated Bionector neutral-displacement needle-free valve with flat, swabable septum.
  • Clamp: integrated flat clamp on the tubing for on/off flow control.
  • Connections: male luer-locking collar at the catheter end; internal female luer within Bionector for syringe/line connection.
  • Latex-free, PVC-free and DEHP-free construction.
  • Non-pyrogenic, sterile, single-use device (as per Vygon Bionector/Octopus 1 technical information).

Formulation

  • Single-lumen IV extension line from Vygon’s Octopus range, made from biocompatible PUR tubing with low dead space.
  • Equipped with Bionector needle-free connector designed to provide neutral displacement, closed-system access and easy disinfection.
  • Flat clamp on the extension tube to allow clinicians to clamp the line during connection, disconnection or when not in use.
  • Rotating male luer-lock collar to connect securely to the female luer hub of IV catheters with minimal torque.
  • Needle-free connection compatible with standard luer syringes and IV sets.
  • Latex-free, PVC-free and DEHP-free materials to minimise allergy risk and avoid plasticiser leaching.

Packaging

  • Individually sterile blister or pouch packed (single unit).
  • Outer box typically contains 50 individually packed extension sets (per Vygon/MedicalExpo listing for code 5222.014).
  • Labelling includes product name (Bionector / Octopus extension), length (10 cm), lumen count (single), manufacturer, reference and lot numbers, and sterility/usage symbols.
  • Packaging clearly marked as latex-free, PVC-free, DEHP-free and single-use only.

Usage

  • Check the expiry date and integrity of the sterile packaging before use; do not use if the package is damaged or opened.
  • Using aseptic technique, open the sterile pack and remove the extension set.
  • Connect the rotating male luer-lock collar securely to the IV catheter hub, ensuring a tight, leak-free connection.
  • Prime the extension line with compatible IV fluid or medication to remove air, using a syringe or infusion line attached to the Bionector; ensure all bubbles are expelled.
  • Disinfect the Bionector septum with an appropriate antiseptic (e.g., 70% alcohol) before each access and allow it to dry, according to local protocol.
  • Attach syringes or infusion sets to the Bionector via standard luer connection for intermittent injections, continuous infusions or blood sampling as required.
  • Use the integrated clamp to control or stop flow when connecting/disconnecting devices or when the line is not in use.
  • Monitor the catheter site and line regularly for signs of leakage, occlusion, kinking or local irritation.
  • After use, close the clamp, disconnect the extension set using aseptic technique and dispose of the entire device in appropriate clinical waste; do not attempt to resterilise or reuse.
  • Always follow local policies, Vygon’s instructions for use and infection-prevention guidelines when handling IV extension sets.

Contraindications

  • Do not use if the sterile package is damaged, opened or past its expiry date.
  • Not suitable for use in patients with known hypersensitivity to polyurethane or any material used in the device.
  • Not intended for arterial lines, epidural use or any application outside those specified for IV infusion and injection.
  • Do not use for high-pressure power injection unless specifically indicated as power-injectable for this product code by the manufacturer.
  • Do not use with solutions or drugs that are known to be incompatible with PUR tubing or the Bionector valve materials.

Adverse Effects

  • If aseptic technique is not followed, risk of local or systemic infection at the catheter site.
  • Potential for catheter-related complications such as phlebitis, infiltration or occlusion if the line is kinked, misconnected or not monitored properly.
  • Possible air embolism if the extension line is not fully primed before connection to the patient.
  • Rare hypersensitivity or allergic reactions to device materials in susceptible individuals.
  • Drug incompatibility issues or precipitation if incompatible medications are infused through the same line without appropriate flushing.

Storage Conditions

  • Store in a clean, dry place at room temperature, away from direct sunlight and sources of heat.
  • Keep in original packaging until point of use to maintain sterility and protect from contamination or mechanical damage.
  • Do not freeze or expose to extreme temperatures that might compromise the tubing or connector integrity.
  • Keep out of reach of children and unauthorised personnel in clinical environments.

Duration

Intended for single-patient, single-use episodes of IV therapy; the duration of use in situ is determined by clinical judgement, local protocols and catheter dwell-time recommendations, and the set should be replaced if soiled, damaged or at the end of its recommended use period.

Onset

Provides immediate functional benefit upon connection and priming, enabling closed, needle-free IV access and extension of the catheter hub from the time of first use.

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