Injection & 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.
