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Caresite® Smbore Y Leg SpinLL 7 Inch OUS EU Box of 100

Caresite® Smbore Y Leg SpinLL 7 Inch OUS EU Box of 100

Caresite

Injection & Infusion
  • CE Marked medical device for use within the European Economic Area (EEA), as indicated by manufacturer and EU distributors.
  • Designed and manufactured in accordance with applicable European medical device regulations and standards declared by B. Braun.
  • Latex Free construction as specified in manufacturer documentation.
  • DEHP Free tubing and components as specified for Caresite® extension sets.
  • Needle Free IV access system aligned with infusion therapy and infection prevention standards referenced by the manufacturer.
Smallbore Y-extension IV set / double extension set

Description

Caresite® Smbore Y-Leg SpinLL (REF 470106-01) is a bifurcated smallbore Y-extension IV set equipped with two needle-free Caresite® membrane valves and Spin-Lock luer technology. It is designed for infusion therapy to extend IV lines and provide two closed, needle-free access points for aspiration, injection, transfusion and blood sampling. The set has 18 cm (7\) smallbore tubing with 1.3 mm inner diameter, a priming volume of 0.9 ml, flow rate of approximately 86.3 ml/min and a maximum working pressure of 2.0 bar (about 29 psi). The distal end has a male Luer-Lock (Spin-Lock) connector and the two proximal branches each terminate in a Caresite® needle-free valve. The device is supplied sterile in peel packs and is intended for single use.

Bnefits

  • Provides two needle-free Caresite® access ports to reduce needlestick injury risk and support closed-system infusion therapy.
  • Bifurcated smallbore Y design allows simultaneous or sequential connection of multiple infusions or intermittent injections via one catheter.
  • Low priming volume (0.9 ml) and 1.3 mm smallbore tubing help minimise dead space and fluid volume, beneficial for fluid-sensitive patients.
  • Spin-Lock luer connection at the distal end provides a secure, leak-resistant connection to the IV catheter or primary line.
  • Positive-displacement Caresite® valve design supports effective flushing and helps reduce catheter occlusion.
  • Latex- and DEHP-free tubing helps reduce the risk of hypersensitivity reactions and exposure to plasticisers.
  • Closed, swabbable valve surface facilitates disinfection and helps reduce microbial contamination of the IV line.
  • High-pressure-compatible Caresite® technology (per selected configurations) supports flexibility in infusion therapy when used according to IFU.
  • Sterile, single-use device reduces cross-contamination risk compared with reusable connectors.
  • Compatible with standard luer-lock syringes and IV administration sets used in hospital, clinic and veterinary environments.

Indications

  • Extension of intravenous infusion lines where two needle-free access points are required from a single catheter or primary line.
  • Use in infusion therapy for the administration of IV fluids, medications and compatible blood products via a luer-lock IV catheter.
  • Intermittent injection, aspiration and blood sampling through needle-free Caresite® valves in a closed IV system.
  • Use in general hospital, outpatient, intensive care and veterinary settings where smallbore extension sets with needle-free valves are clinically indicated.

Composition

  • Bifurcated smallbore extension tubing, approximate length 18 cm (7") with inner diameter 1.3 mm.
  • Two Caresite® needle-free membrane valves (luer-activated split septum, positive displacement).
  • Distal male Luer-Lock (Spin-Lock) connector for secure attachment to IV catheters or administration sets.
  • Latex-free, DEHP-free polymer tubing and connectors as specified by the manufacturer.
  • Sterile packaging materials (peel-pack pouches and outer carton).

Formulation

  • Single-use, sterile, bifurcated smallbore Y-extension IV set with two needle-free Caresite® valves and Spin-Lock male Luer-Lock connector.
  • Non-medicinal medical device (no active pharmaceutical ingredient).

Packaging

  • Individual sterile peel-pack pouches containing one Caresite® Smbore Y-Leg SpinLL extension set.
  • Box of 100 individually packed extension sets for the OUS-EU configuration.
  • Labelled with REF 470106-01, product description, sterility symbol, lot number and expiry date as per manufacturer labelling.

Usage

  • Verify the product reference (470106-01), integrity of the sterile peel pack and expiry date before use; do not use if the packaging is damaged or opened.
  • Using aseptic technique, open the peel pack immediately before use and remove the extension set without contaminating the connectors or valve surfaces.
  • Connect the distal male Luer-Lock (Spin-Lock) connector securely to the IV catheter hub or primary infusion line, ensuring a tight luer-lock connection.
  • Prime the extension set with the prescribed IV solution according to institutional protocol, removing all visible air from the tubing and valves.
  • Before each access, disinfect the Caresite® valve surface with an appropriate antiseptic swab and allow to dry as per local guidelines.
  • Connect syringes or secondary lines using standard luer connection and perform infusion, injection, aspiration or blood sampling according to clinical protocol.
  • After each use, flush the line per institutional policy (e.g., saline flush) to clear residual fluid and help maintain catheter patency.
  • Do not exceed the specified maximum working pressure of 2.0 bar (approximately 29 psi).
  • The device is intended for single use only; do not resterilize or reuse. Dispose of the used extension set according to local regulations for medical waste.
  • Follow all additional instructions for use (IFU) and institutional policies related to IV therapy and needle-free connectors.

Contraindications

  • Do not use in patients with known hypersensitivity to any materials used in the device (e.g., specific polymers) if such sensitivity is identified.
  • Do not use if the sterile packaging is damaged, opened or wet, or if the expiry date has passed.
  • Do not use if any component of the extension set appears damaged, discoloured, occluded or otherwise compromised.
  • Do not reuse or resterilize; single-use only.
  • Do not exceed the manufacturer-specified maximum working pressure (2.0 bar).

Adverse Effects

  • Potential catheter-related bloodstream infection if aseptic technique and valve disinfection protocols are not followed.
  • Local phlebitis, irritation or thrombosis at the catheter insertion site associated with IV therapy in general.
  • Catheter occlusion or impaired flow if flushing protocols are inadequate or if precipitates form in the line.
  • Leakage or disconnection-related complications if connections are not properly secured.
  • Rare hypersensitivity or allergic reactions to device materials in susceptible individuals.
  • Air embolism risk if the extension set and connected system are not fully primed and de-aired before use.

Storage Conditions

  • Store in the original packaging in a clean, dry environment.
  • Keep at room temperature away from direct sunlight and sources of heat or moisture, within the temperature range specified on the packaging.
  • Protect from mechanical damage, crushing or bending that could compromise tubing or connectors.
  • Do not freeze, and avoid exposure to extreme temperatures.
  • Keep out of reach of unauthorised persons to maintain sterility and product integrity.

Duration

Used for the duration of an IV infusion episode or as per institutional policy; replace the extension set when clinically indicated, when the IV line is changed, or if integrity is compromised.

Onset

Immediate functionality upon correct connection and priming of the IV line.

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