Combi Stopper (Syringe Bung) x 100
B. Braun
Medical DeviceInjection & Infusion accessories / Luer lock syringe and IV closure caps
Certifications
- Classified and marketed as a sterile medical device accessory for infusion and injection systems.
- Complies with relevant EU medical device standards and directives and carries a CE conformity mark (per B. Braun and distributor documentation for Combi Stopper closure cones).
- Manufactured without BPA, DEHP, PVC or natural rubber latex to reduce patient exposure to sensitising or harmful materials.
- Non Toxic and non Pyrogenic, suitable for use with standard infusion solutions including alcohol and lipids within typical clinical practice.
- Classified and marketed as a sterile medical device accessory for infusion and injection systems.
- Complies with relevant EU medical device standards and directives and carries a CE conformity mark (per B. Braun and distributor documentation for Combi Stopper closure cones).
- Manufactured without BPA, DEHP, PVC or natural rubber latex to reduce patient exposure to sensitising or harmful materials.
- Non Toxic and non Pyrogenic, suitable for use with standard infusion solutions including alcohol and lipids within typical clinical practice.
Injection & Infusion accessories / Luer lock syringe and IV closure caps
Description
The B. Braun Combi Stopper (Syringe Bung) is a universal, single-use closing cone supplied in boxes of 100, designed for the sterile closure of all kinds of open male or female luer and luer-lock (and luer-slip) IV access sites, including IV giving sets, IV catheters and pre-filled syringes. Made from polyethylene (PE), the double-ended stopper provides both male and female luer lock fittings, enabling secure, hygienic and contact-free closure of infusion systems and syringe assemblies. Each combi stopper is individually sterile packed, non-toxic, non-pyrogenic and free from BPA, DEHP, latex and PVC, making it suitable for use in a wide range of clinical settings, including infusion therapy, emergency care and aesthetic injection practice.
Bnefits
- Provides sterile closure of open IV-access sites, IV sets, IV catheters and pre-filled syringes
- Double-ended design closes both male and female luer and luer-lock (and luer-slip) connections
- Helps maintain a closed, hygienic system and reduces risk of contamination between uses
- Individually sterile packed for single-patient, single-use application
- Made of polyethylene (PE), non-toxic and non-pyrogenic
- Not manufactured with BPA, DEHP, PVC or natural rubber latex
- Compatible with alcohol and lipid-containing solutions in standard infusion use
- Pressure resistant (up to approximately 2 bar as specified for B. Braun Combi-Stoppers)
- Compact, lightweight and easy to stock in procedure trolleys, emergency kits and home-visit bags
Indications
- Sterile temporary closure of pre-filled syringes between preparation and administration
- Closure of open ports on IV infusion sets and IV catheters when not in immediate use
- Maintenance of closed systems during intermittent infusion or injection therapy
- Use in hospital wards, theatres, ICU, emergency and pre-hospital settings
- Use in outpatient clinics and aesthetic practices for safe syringe and IV line management
Composition
- Polyethylene (PE) body
- Free from BPA (Bisphenol A)
- Free from DEHP (Di(2-ethylhexyl) phthalate)
- Free from natural rubber latex
- Free from PVC
- Non-toxic and non-pyrogenic materials
Formulation
- Single-use plastic closing cone with luer lock fittings (male and female ends)
- Universal design suitable for both male and female luer and luer-lock (and luer-slip) connectors
- Sterilised (typically by radiation according to distributor information for B. Braun combi stoppers)
- Medical device accessory for infusion and injection systems (non-drug, non-biological)
Packaging
- Box of 100 Combi Stopper closing cones
- Each stopper individually sterile packed
- Available in various colours (red, blue, white) depending on supplier variant
- Supplied as part of the B. Braun infusion and injection accessories range
Usage
- Check the integrity of the individual sterile package before use; do not use if the packaging is damaged.
- Disinfect the luer or luer-lock connection to be closed according to local protocol.
- Select the appropriate end of the combi stopper (male or female) to match the connector.
- Attach the combi stopper to the luer or luer-lock connection, ensuring it is fully seated and secure.
- Leave in place for the required period to maintain a closed, sterile system.
- Remove and discard the combi stopper according to local infection-control and sharps/waste policies when access is again required.
- Intended for single use only; do not re-sterilise or reuse.
Contraindications
- Do not use if the sterile package is open, damaged or compromised before use.
- Not suitable as a patient-access device or for direct infusion/injection; it is intended only as a closure cap.
- Do not use on connectors or systems that are incompatible with standard luer or luer-lock dimensions.
- Use with caution where system pressures exceed the specified pressure resistance (approximately 2 bar) or where local protocols prohibit use of such caps.
- Do not reuse or re-sterilise; single-use only.
Adverse Effects
- No specific adverse reactions are associated with correct use; potential risks relate to device misuse or loss of sterility.
- Improper application or use of a non-sterile/compromised stopper may increase risk of catheter or line-related infection.
- Insufficiently secured stoppers may lead to fluid leakage or disconnection of closed systems.
- Any suspected device-related incident should be reported via local pharmacovigilance or medical device reporting systems.
Storage Conditions
- Store in a clean, dry environment at room temperature.
- Protect from excessive heat, moisture and direct sunlight.
- Keep in original packaging until point of use to maintain sterility.
- Keep out of reach of unauthorised persons, children and non-clinical areas.
Duration
Used on-demand during infusion or injection procedures and for as long as a closed, sterile luer or luer-lock connection is required; removed when the line or syringe is accessed again.
Onset
Immediate mechanical effect upon correct application, providing sterile closure and sealing of the luer or luer-lock connection.
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