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Safeflow Valve Box of 50

Safeflow Valve Box of 50

Safeflow

Injection & Infusion
  • CE Marked medical device for needle Free IV access (B. Braun Safeflow).
  • Not manufactured with PVC, DEHP or latex/natural rubber.
  • Pressure resistance tested up to 2 bar, 400 psi for 60 seconds and 1,200 psi for 30 seconds in open position.
  • Validated for approximately 300 activations per valve.
  • Designed as a closed system according to NIOSH definition for needle Free connectors.
  • Manufactured under ISO 13485 Compliant quality management systems for medical devices.
Needle-free IV connectors / injection-infusion valves

Description

Safeflow is a needle-free injection/infusion valve from B. Braun, designed to provide safe, closed-system access for the preparation and administration of IV therapies. The luer-activated connector offers a straight fluid pathway with uninterrupted flow, supporting rapid drug delivery, blood sampling and infusions while reducing the risk of needlestick injuries. The swabable membrane forms an effective microbial barrier when properly disinfected, helping to prevent bloodstream infections and chemical contamination. Safeflow is compatible with both Luer-slip and Luer-lock connections, is not manufactured with PVC, DEHP or latex/natural rubber, and is pressure resistant up to 2 bar (400 psi for 60 seconds and 1,200 psi for 30 seconds in the open position). Each sterile, single-use valve is tested for up to 300 activations and can be used for adults, paediatric and neonate patients according to IV therapy prescriptions.

Bnefits

  • Provides needle-free IV access for injection, aspiration and parallel infusions, reducing the risk of needlestick injuries.
  • Straight fluid pathway delivers uninterrupted flow for rapid drug administration and optimal flow rates (approx. 360 mL/min).
  • Closed, swabable valve system designed to prevent microbial ingress and escape of contaminants, supporting infection prevention.
  • Luer-activated connector compatible with both Luer-slip and Luer-lock syringes and IV sets.
  • Smooth, flat membrane surface allows easy disinfection according to CDC, national or hospital guidelines; alcohol-resistant.
  • Can be effectively flushed clear of blood and fluids, maintaining patency and reducing occlusion risk.
  • Pressure resistant up to 2 bar and suitable for high-pressure applications (400 psi for 60 seconds, 1,200 psi for 30 seconds in open position).
  • Not made with PVC, DEHP or latex/natural rubber, reducing the risk of plasticizer exposure and allergic reactions.
  • Tested for approximately 300 activations, allowing multiple accesses for direct aspiration or injection on a single line.
  • Small, lightweight design integrates easily into a variety of IV systems and medical devices.

Indications

  • Needle-free access to IV lines for administration of medications, fluids and blood products.
  • Aspiration of blood samples via an existing IV line without the use of needles.
  • Parallel infusions and intermittent injections through a closed IV system.
  • Use in adult, paediatric and neonate patients requiring IV therapy.
  • Replacement for conventional stylets or injection caps on compatible IV lines and devices.

Composition

  • Housing made from medical-grade plastic (e.g. polycarbonate) designed for compatibility with common IV drugs and fluids.
  • Internal silicone or elastomeric valve/membrane providing a swabable, self-sealing septum.
  • Luer-compatible female port for connection to male Luer-slip or Luer-lock devices.
  • Materials specifically not manufactured with PVC, DEHP or latex/natural rubber.

Formulation

  • Luer-activated, negative-displacement needle-free connector.
  • Straight fluid path design for uninterrupted flow and rapid delivery.
  • Priming volume approximately 0.09 mL.
  • Nominal flow rate approximately 360 mL/min under standard conditions.
  • Pressure resistance: up to 2 bar; approx. 400 psi for 60 seconds and 1,200 psi for 30 seconds in open position.
  • Validated for up to 300 activations per valve under specified test conditions.

Packaging

  • Box of 50 Safeflow needle-free valves.
  • Each valve supplied individually sterile-packed for single patient use.
  • Outer carton labelled with product name, brand, REF 409100H, lot number, expiry date and relevant regulatory marks.

Usage

  • Inspect the packaging before use; do not use if the sterile pack is damaged, opened or past the expiry date.
  • Maintain aseptic technique when opening the sterile pack and handling the valve.
  • Attach the Safeflow valve securely to the IV catheter hub, extension set or other compatible Luer connection by engaging the Luer-lock or Luer-slip fitting.
  • Before each access, disinfect the swabable membrane using an appropriate antiseptic (e.g. alcohol swab) and allow it to dry according to local policy.
  • Connect a Luer-slip or Luer-lock syringe or IV set straight onto the valve to activate it and open the fluid channel.
  • Administer infusions, inject medications or aspirate blood as prescribed, ensuring connections remain secure during use.
  • Flush the valve and line as per institutional protocol to clear blood or residual drugs and maintain patency.
  • After disconnecting the syringe or IV set, the valve automatically returns to a closed position to maintain a closed system and minimise the risk of air or microbial ingress.
  • Replace the Safeflow valve at intervals defined by CDC, national guidelines or hospital protocol (commonly up to 7 days or sooner if contamination or malfunction is suspected).
  • Dispose of the used valve as clinical waste in accordance with local regulations; do not reprocess or reuse.

Contraindications

  • Do not use if the sterile package is damaged, opened or expired.
  • Not intended for use with non-Luer-compatible connectors or systems.
  • Do not use in patients with known hypersensitivity to any component materials if such reactions have been identified.
  • Do not use for purposes other than IV infusion, injection, aspiration or blood sampling via compatible Luer connections.
  • Do not use if visible damage, cracking, discoloration or malfunction of the valve is observed.

Adverse Effects

  • Potential risk of catheter-related bloodstream infection if aseptic technique and proper disinfection of the membrane are not followed.
  • Risk of air embolism if the system is not properly primed or if disconnections occur without clamping according to protocol.
  • Possible leakage or disconnection if the Luer connection is not secured correctly.
  • General IV therapy-related risks such as phlebitis, thrombosis or extravasation, which are associated with the IV catheter rather than the valve itself.
  • Rare risk of hypersensitivity or local irritation related to device materials in susceptible individuals.

Storage Conditions

  • Store in original, unopened packaging in a clean, dry environment.
  • Keep at room temperature within the range specified on the packaging; avoid extreme heat or freezing.
  • Protect from direct sunlight and excessive moisture.
  • Do not use after the expiry date indicated on the packaging.
  • Keep out of reach of children and unauthorised personnel.

Duration

Single-use, multi-access device on an individual IV line; may remain in place and be used for multiple activations for up to the duration recommended by CDC, national guidelines or hospital protocol (commonly up to 7 days) before replacement.

Onset

Immediate upon connection and activation; provides needle-free access and closed-system functionality as soon as installed on the IV line.

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