5ml PosiFlush XS (Externally Sterile) Pack of 30
Becton Dickinson
Injection & infusion consumablePrefilled 0.9% sodium chloride IV flush syringe (externally sterile)
Certifications
- CE Marked medical device compliant with applicable European medical device legislation for prefilled saline flush syringes
- Manufactured under BD’s ISO 13485 Certified quality management system for medical devices
- Sterility validated to a sterility assurance level (SAL) of 10⁻⁶ using moist Heat terminal sterilisation in accordance with relevant ISO and EN standards
- Biocompatibility assessed in line with ISO 10993 series for materials in contact with the vascular system
- Labelling and symbols compliant with EN ISO 15223 1 and EN 1041 for information supplied by the manufacturer
- Latex Free, DEHP Free and BPA Free construction consistent with BD regulatory and safety disclosures
- CE Marked medical device compliant with applicable European medical device legislation for prefilled saline flush syringes
- Manufactured under BD’s ISO 13485 Certified quality management system for medical devices
- Sterility validated to a sterility assurance level (SAL) of 10⁻⁶ using moist Heat terminal sterilisation in accordance with relevant ISO and EN standards
- Biocompatibility assessed in line with ISO 10993 series for materials in contact with the vascular system
- Labelling and symbols compliant with EN ISO 15223 1 and EN 1041 for information supplied by the manufacturer
- Latex Free, DEHP Free and BPA Free construction consistent with BD regulatory and safety disclosures
Prefilled 0.9% sodium chloride IV flush syringe (externally sterile)
Description
The BD PosiFlush XS 5 mL Prefilled Saline Syringe (Externally Sterile) is a ready-to-use, single-use syringe containing sterile 0.9% sodium chloride solution for flushing indwelling vascular access devices. The XS configuration is terminally sterilised in its peel pouch so it can be aseptically presented to a sterile field, making it suitable for speciality procedures such as PICC or CVC insertion, oncology treatments, interventional radiology and critical care where sterile-field technique is required. The syringe features a BD Luer-Lok tip and a standard 10 mL barrel diameter to help control flush pressure and support catheter integrity, while the externally sterile packaging allows presentation directly into sterile fields by clinicians wearing sterile gloves.
Bnefits
- Externally sterile (XS) syringe presented in a terminally sterilised peel pouch, enabling aseptic presentation to a sterile field
- Designed for flushing indwelling vascular access devices, supporting catheter patency and reducing the risk of occlusion
- Particularly suited for oncology, interventional radiology and critical care environments, including PICC and CVC insertions
- Ideal for specialty IV flush procedures performed with sterile gloves, within a sterile field or in severely immunosuppressed patients
- Ready-to-use 0.9% sodium chloride prefilled syringe eliminates the need for manual preparation from vials or ampoules, improving efficiency and standardisation
- Standard 10 mL barrel diameter (even for 5 mL volume) helps limit injection pressure and reduces the risk of catheter damage, in line with PICC manufacturer recommendations
- BD Luer-Lok tip provides secure connection to vascular access devices, helping prevent leaks and disconnections
- Individually packaged, single-use and preservative-free, supporting best practice in infection prevention and medication safety
- Three-year shelf life under recommended storage conditions facilitates stock management and reduces waste
Indications
- Flushing indwelling vascular access devices (e.g., peripheral IV catheters, PICCs, CVCs, implanted ports) with 0.9% sodium chloride solution
- Use during sterile procedures such as PICC or CVC insertions where sterile field maintenance is required
- Oncology procedures involving central venous access in patients at high risk of infection or who are severely immunosuppressed
- Interventional radiology procedures requiring aseptic handling of vascular access devices
- Critical care settings where sterile-field IV flushing is required
- Any situation where flush syringes must be aseptically presented onto a sterile field while wearing sterile gloves
Composition
- Sterile 0.9% sodium chloride injection (sodium chloride 0.9% w/v in water for injection), isotonic with blood
- Water for injection as diluent
- No added preservatives
- Syringe barrel: medical-grade polypropylene
- Plunger rod: medical-grade plastic (polypropylene or equivalent)
- Plunger stopper: medical-grade elastomer compatible with saline (latex-free)
- Tip cap: compatible elastomer/plastic forming a sterile closure of the fluid pathway
- Device is latex-free, DEHP-free and BPA-free according to BD product specifications
Formulation
- Single-use, three-piece plastic syringe prefilled with 5 mL of sterile 0.9% sodium chloride solution
- Fill volume: 5 mL; syringe barrel outer diameter equivalent to a standard 10 mL syringe to reduce flush pressure
- Integrated BD Luer-Lok tip for secure catheter connection
- Externally sterile (XS): syringe and its outer surface are sterile inside a terminally sterilised peel pouch, allowing placement on a sterile field
- Non-pyrogenic, preservative-free saline solution
- Terminal sterilisation by moist heat (steam) to a sterility assurance level (SAL) of 10⁻⁶
- Clearly printed and colour-coded labelling with barcodes for product identification and inventory control
Packaging
- Unit: one 5 mL BD PosiFlush XS prefilled saline syringe in an individually terminally sterilised peel pouch
- Box: 30 syringes per pack (Pack of 30)
- Outer case: multiple boxes per shipping carton as specified by BD and distributors
- Each pouch labelled with product name, reference number (306571), lot number, expiry date, 0.9% sodium chloride concentration and XS (externally sterile) designation
- Carton labelling includes quantity, storage conditions, manufacturer and regulatory symbols
Usage
- For use by trained healthcare professionals only; follow institutional policies and the official BD Instructions for Use (IFU).
- Indicated for flushing indwelling vascular access devices using 0.9% sodium chloride to maintain catheter patency and help prevent occlusion.
- Designed specifically for situations requiring sterile-field presentation, such as when wearing sterile gloves, working within a sterile field or treating severely immunosuppressed patients.
- Before use, verify package integrity and expiry date. Do not use if the peel pouch is damaged, if sterility is compromised or if the solution appears cloudy, discoloured or contains visible particles.
- Open the peel pouch aseptically and present the sterile syringe onto the sterile field in accordance with local sterile-field procedures.
- Maintain aseptic technique, remove the tip cap, and expel any air from the syringe following local protocol while avoiding spray.
- Attach the BD Luer-Lok tip securely to the vascular access device hub and flush using the volume and technique recommended for the specific catheter type and clinical situation.
- Use pulsatile (start–stop) flushing and positive-pressure disconnection techniques if recommended by institutional protocols to reduce reflux and maintain patency.
- For flushing only: do not use the syringe for drug admixture, medication administration, or reconstitution of medicines.
- Single use only. Do not re-sterilise or reuse. After use, dispose of the syringe and any unused solution in an appropriate sharps container in accordance with local regulations and infection control policies.
Contraindications
- Known hypersensitivity or allergy to sodium chloride or any component of the syringe or stopper materials, although such reactions are rare.
- Situations where administration of additional sodium or fluid volume is contraindicated (e.g., in certain patients with severe hypernatremia or fluid overload), unless specifically assessed and approved by the responsible clinician.
- Do not use if the pouch or syringe packaging is damaged, if sterility is compromised, or if the saline solution is cloudy, discoloured or contains visible particulates.
- Not to be used for medication mixing, reconstitution, dilution or direct IV medication administration; indicated for flushing only.
- Use with caution or according to specialist advice in patients with clinically significant electrolyte imbalances where even small volume saline flushes may need to be tightly controlled.
Adverse Effects
- When used appropriately for flushing with 0.9% sodium chloride, adverse reactions are uncommon; mild local discomfort at the catheter site may occur.
- Incorrect technique or excessive pressure may contribute to catheter or vascular injury, infiltration or extravasation.
- As with any vascular access procedure, there is a potential risk of infection if aseptic technique is not strictly followed.
- Systemic effects from the small volume of saline used for flushing are unlikely in most patients but may be relevant in those with severe fluid or sodium restrictions.
- Any suspected adverse events or device malfunctions should be managed according to local policy and reported via appropriate medical device vigilance systems.
Storage Conditions
- Store at controlled room temperature as indicated on the packaging (typically 15°C to 25°C), away from excessive heat and direct sunlight.
- Keep syringes in their original sterilised peel pouches and cartons until use to maintain sterility.
- Do not freeze the product.
- Observe the expiry date printed on each pouch and carton; BD PosiFlush XS syringes typically have a shelf life of up to 3 years when stored under recommended conditions.
- Follow institutional stock rotation practices (e.g., first-expiry-first-out) to ensure older stock is used before newer stock.
Duration
Not applicable as a defined treatment course; the 5 mL BD PosiFlush XS syringe is used episodically for individual flushes according to vascular access maintenance protocols and clinical need.
Onset
Immediate mechanical effect at the time of flushing, maintaining or restoring catheter patency when used according to vascular access device care protocols.
