BD Plastipak™ 50 mL Eccentric Luer Slip Syringe (Box of 60)

Becton Dickinson

Medical device – syringe

Sterile 3-piece general purpose syringe, 50 mL eccentric Luer slip, without needle

CE Marked medical device (CE 0318) under the European Medical Devices regulatory framework for general purpose syringes.
Manufactured in San Agustín, Spain under an ISO 13485 Certified quality management system for medical devices.
Conforms to relevant ISO standards for single Use hypodermic syringes (e.g. ISO 7886 1) relating to performance, leak tightness and graduation accuracy, as detailed in BD Plastipak™ technical documentation.
Ethylene oxide sterilisation validated and controlled in accordance with EN ISO 11135 and associated standards for sterilisation of healthcare products.
Biocompatibility evaluated according to ISO 10993 series standards for materials in contact with blood and bodily fluids in the intended use.
Packaging and sterile barrier systems validated in line with EN ISO 11607 for terminally sterilised medical devices.
BD Plastipak™ syringes technical data sheet confirms that products are sterile, single Use, latex Free and tested for sterility, pyrogenicity and toxicity.
GTIN and packaging configuration (each, shelf box and case) registered and referenced in BD product specifications.
Device listed on BD’s official product catalogue and supported by electronic Instructions for Use (eIFUs) via BD’s eIFU portal.

CE Marked medical device (CE 0318) under the European Medical Devices regulatory framework for general purpose syringes.
Manufactured in San Agustín, Spain under an ISO 13485 Certified quality management system for medical devices.
Conforms to relevant ISO standards for single Use hypodermic syringes (e.g. ISO 7886 1) relating to performance, leak tightness and graduation accuracy, as detailed in BD Plastipak™ technical documentation.
Ethylene oxide sterilisation validated and controlled in accordance with EN ISO 11135 and associated standards for sterilisation of healthcare products.
Biocompatibility evaluated according to ISO 10993 series standards for materials in contact with blood and bodily fluids in the intended use.
Packaging and sterile barrier systems validated in line with EN ISO 11607 for terminally sterilised medical devices.
BD Plastipak™ syringes technical data sheet confirms that products are sterile, single Use, latex Free and tested for sterility, pyrogenicity and toxicity.
GTIN and packaging configuration (each, shelf box and case) registered and referenced in BD product specifications.
Device listed on BD’s official product catalogue and supported by electronic Instructions for Use (eIFUs) via BD’s eIFU portal.

Sterile 3-piece general purpose syringe, 50 mL eccentric Luer slip, without needle

Description

The BD Plastipak™ 50 mL Eccentric Luer-Slip Syringe (REF 300866) is a sterile, single-use, 3-piece syringe without needle designed for general purpose injection and aspiration of fluids. It features a clear polypropylene barrel with bold graduations, a polypropylene plunger rod and a latex-free rubber stopper that provides a secure seal and smooth movement. The syringe has an eccentric Luer-Slip Tip™ positioned off-centre (side nozzle) to allow low-angle injections close to the skin and improved control for aspiration or administration. It is intended for injection of medicinal substances, blood extraction and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin. The device is CE-marked, ethylene-oxide sterilised, supplied individually in sterile blister packs and boxed in quantities of 60 syringes.

Bnefits

General purpose 3-piece syringe for injection of medicinal substances, blood extraction and aspiration of fluids from vials, ampoules and subcutaneous/other below-skin sites.
Eccentric Luer-Slip Tip™ (side nozzle) allows the syringe to be held closer to the skin surface for certain injections and aspirations, improving access and ergonomics in specific procedures.
Clear, transparent barrel with easy-to-read black graduation marks in 1 mL increments supports accurate measurement and dosing of up to 50 mL.
Three-piece construction with latex-free stopper helps prevent leakage around the plunger and provides smooth, controlled plunger travel and good feel during aspiration and injection.
Individually sterile-packed syringes support aseptic technique and infection prevention across different clinical areas.
Latex-free and sterile, single-use design reduces the risk of allergic reactions and cross-contamination when used according to instructions.
High-capacity 50 mL format makes the syringe suitable for large-volume injections, flushing, aspiration or use with syringe drivers and pumps where compatible.
BD Plastipak™ range is tested for sterility, pyrogenicity and toxicity, and manufactured under ISO 13485-certified quality systems for consistent performance.
Compatible with standard Luer-taper needles and devices designed for Luer slip connections, enabling versatile clinical use in hospitals, clinics, laboratories and veterinary practice.
5-year shelf life from manufacture when stored correctly, supporting efficient stock management and reduced wastage.

Indications

General purpose injection of medicinal substances using an appropriate needle or compatible delivery device attached to the Luer slip eccentric tip.
Aspiration of blood and other bodily fluids from parts of the body below the surface of the skin when used with a suitable needle or cannula.
Aspiration, transfer and measurement of fluids from vials, ampoules and other containers as part of drug preparation and administration.
Use as a high-capacity (50 mL) syringe for flushing, irrigation or large volume injections where an eccentric tip syringe is clinically advantageous.
Use in combination with compatible syringe-driver and infusion pump equipment where 50 mL Plastipak syringes are approved and specified by the device manufacturer.
Single-use applications in hospital, primary care, outpatient, emergency, theatre, intensive care, laboratory and veterinary settings.

Composition

Barrel: Medical-grade polypropylene, transparent.
Plunger rod: Medical-grade polypropylene.
Stopper: Latex-free elastomer rubber stopper (synthetic), providing a tight seal and smooth plunger motion.
Lubrication: Silicone oil or equivalent medical-grade lubricant applied to the stopper/barrel interface to reduce sliding friction.
Tip: Integrated eccentric Luer-Slip Tip™ (Luer taper) formed from the same polypropylene barrel material.
Primary unit packaging: Blister pack formed from medical-grade film (e.g. polyamide/polyethylene) with medical paper or film lid, providing a sterile barrier.
Shelf/carton packaging: Printed cardboard carton for 60 sterile-packed syringes.
Materials of concern: Not made with natural rubber latex; does not contain PVC or DEHP in the syringe components as per BD Plastipak™ technical documentation.

Formulation

Nominal capacity: 50 mL.
Graduation scale: 1 mL increments on a 50 mL transparent barrel.
Design: 3-piece syringe (barrel, plunger rod and latex-free stopper).
Tip design: Luer-Slip Tip™ eccentric (side nozzle).
Usage: Sterile, single-use, disposable; intended for manual injection and aspiration and for use with compatible syringe drivers and pumps as specified.
Sterilisation: Ethylene oxide (EO) sterilised.
Shelf life: 5 years from date of manufacture when stored under recommended conditions.
CE certification: CE-marked, CE 0318, under EU Medical Devices Directive/Regulation for general purpose syringes.
Manufacturing country: San Agustín, Spain (BD manufacturing site).
GTIN – Each: 00382903008667; GTIN – Shelf pack (box of 60): 30382903008668; GTIN – Case (240 units): 50382903008662.

Packaging

Unit level: 1 sterile 50 mL eccentric Luer slip syringe per primary blister pack.
Shelf pack: 60 individually sterile blister-packed syringes per box for REF 300866.
Shipping case: 240 syringes per case (4 shelf boxes of 60).
Outer carton labelling includes product name, brand (BD Plastipak™), reference number (300866), capacity (50 mL), tip type (Luer-Slip Tip™ eccentric), lot number, expiry date, sterility method, storage symbols, CE mark and manufacturer details.
Medisave/retail configuration: Supplied as BD ECC Luer Slip Syringes 50 mL x 60, typically shrink-wrapped cardboard cartons for distribution.

Usage

Use only by trained healthcare or veterinary professionals familiar with injection and aspiration techniques and institutional protocols.
Before use, inspect the outer carton and individual sterile blister pack; do not use the syringe if the sterile barrier is damaged, opened or if the expiry date has passed.
Open the blister aseptically and remove the syringe, taking care not to touch or contaminate the Luer slip tip or internal surfaces.
Attach an appropriate sterile needle or compatible device to the eccentric Luer-Slip Tip™ by pushing firmly onto the Luer taper and twisting slightly to ensure a secure friction fit.
For fluid aspiration (e.g. from vials or ampoules), insert the needle or device into the fluid and retract the plunger slowly while keeping the tip submerged; verify the required volume using the 1 mL graduation marks and remove air bubbles according to local procedures.
For injections, expel air from the syringe and needle according to standard practice, position and insert the needle using the appropriate technique for the intended route, then depress the plunger at a controlled rate to administer the medication.
For blood sampling or aspiration from the patient, apply negative pressure smoothly via the plunger while maintaining proper needle or cannula placement and patient safety.
If used with a syringe driver or infusion pump, follow the pump manufacturer’s instructions for loading, securing and calibrating the 50 mL BD Plastipak™ syringe and verify correct size selection on the device.
Do not over-force the plunger at the end of travel to avoid potential damage or disconnection; do not attempt to modify or alter the syringe.
After use, activate any relevant needle safety devices (if applicable to the needle used), then dispose of the syringe and needle immediately into an approved sharps/clinical waste container, in accordance with local regulations.
The syringe is intended strictly for single use; do not attempt to clean, reprocess or resterilise.
Always follow applicable local, national and institutional guidelines, as well as BD Plastipak™ product literature and electronic Instructions for Use (eIFUs).

Contraindications

Do not use if the sterile blister pack is open, torn, wet or otherwise compromised, or if the product is past its expiry date.
Do not reuse, reprocess or resterilise; reuse may lead to loss of sterility, infection, malfunction or inaccurate dosing.
Do not use with solutions known to be incompatible with polypropylene, rubber stopper material or silicone lubricant; check compatibility data before use with non-standard or solvent-containing preparations.
Do not use if the syringe barrel, tip, plunger rod or stopper appears cracked, discoloured, deformed or otherwise damaged.
Do not use in situations where a locking connector (Luer-Lok) is specifically required for safety or high-pressure applications; an eccentric Luer slip tip provides a friction fit only.
Avoid use in patients with known hypersensitivity to any syringe component if clinically relevant, although the syringe is not made with natural rubber latex and is supplied sterile.
Do not use as an implantable device or leave the syringe in situ; it is intended only as a transient instrument for injection/aspiration or use within an external pump system.

Adverse Effects

Potential for local or systemic infection or sepsis if aseptic technique is not properly followed, or if the syringe is reused contrary to instructions for single use.
Risk of air embolism if the syringe and any connected devices are not correctly primed and air is inadvertently injected into the vasculature.
Tissue trauma, bruising or pain associated with the needle or injection technique rather than the syringe itself.
Possible dosing errors due to incorrect reading of the graduation scale or selection of an inappropriate syringe size for the volume required.
Leakage of fluid, disconnection or spillage if the Luer slip connection is not firmly seated or if incompatible devices are connected.
Very rare risk of hypersensitivity or allergic reaction to one of the syringe materials (e.g. stopper or lubricant) in susceptible individuals, although the product is latex-free and designed to be biocompatible.
In pump/syringe-driver use, incorrect pump configuration, size selection or fixation may lead to under- or over-infusion, unrelated to the intrinsic syringe design but associated with the overall system.

Storage Conditions

Store in a dry, reasonably warm environment, away from extremes of temperature, in line with BD Plastipak™ technical data sheet recommendations.
Keep syringes in their original outer carton and individual sterile packs until point of use to maintain sterility and protect from physical damage.
Avoid exposure to strong direct sunlight or high-intensity artificial light for prolonged periods, which may degrade packaging or materials.
Protect cartons from crushing, tearing, moisture and contamination during transport and storage.
Observe any temperature or humidity guidance provided on the packaging or product literature; avoid freezing or storing near heat sources.
Do not use the product after the expiry date printed on the packaging.

Duration

Single-use device designed for one episode of preparation, injection and/or aspiration. It is not intended for repeated use or long-term implantation; overall treatment duration is determined by the clinical regimen and medication protocol rather than by the syringe itself.

Onset

Not directly applicable to the syringe; it provides immediate capability for injection or aspiration once connected and primed. The clinical onset of effect depends on the drug or solution administered, the route of administration and patient factors, not on the syringe.