BD C/N Luer Lok™ Syringes

Becton Dickinson

Medical device – syringe

Sterile 3-piece general purpose syringe, 50 mL Luer-Lok\u2122 tip, without needle

CE Marked sterile, single Use medical device under applicable European medical device legislation for BD Plastipak™ / BD general syringes without needle (including 50 mL Luer Lok™ variants).
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Sterilisation validated according to EN ISO 11135 (ethylene oxide sterilisation of healthcare products) and related standards.
Biocompatibility evaluated according to ISO 10993 series for medical devices used for injection and short Term blood/tissue contact.
Design and performance of Luer Lok™ connection consistent with ISO standards for conical Luer fittings used with syringes and other medical devices (e.g. ISO 594 / ISO 80369 series, as applicable).
Packaging and sterile barrier systems validated according to EN ISO 11607 for terminally sterilised medical devices.
REACH and materials compliance programmes in place; BD technical data for Plastipak™/general syringes state that the product line is not made with natural rubber latex and is not intentionally manufactured with DEHP or PVC for the referenced SKUs.

CE Marked sterile, single Use medical device under applicable European medical device legislation for BD Plastipak™ / BD general syringes without needle (including 50 mL Luer Lok™ variants).
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Sterilisation validated according to EN ISO 11135 (ethylene oxide sterilisation of healthcare products) and related standards.
Biocompatibility evaluated according to ISO 10993 series for medical devices used for injection and short Term blood/tissue contact.
Design and performance of Luer Lok™ connection consistent with ISO standards for conical Luer fittings used with syringes and other medical devices (e.g. ISO 594 / ISO 80369 series, as applicable).
Packaging and sterile barrier systems validated according to EN ISO 11607 for terminally sterilised medical devices.
REACH and materials compliance programmes in place; BD technical data for Plastipak™/general syringes state that the product line is not made with natural rubber latex and is not intentionally manufactured with DEHP or PVC for the referenced SKUs.

Sterile 3-piece general purpose syringe, 50 mL Luer-Lok\u2122 tip, without needle

Description

BD C/N Luer-Lok™ Syringes 50 mL x 60 are sterile, single-use, 3-piece general purpose syringes without needle, featuring a concentric 50 mL BD Luer-Lok™ tip for secure connection to needles and devices. They belong to the BD Plastipak™ / BD general syringe family and are intended for the aspiration and injection of fluids from vials, ampoules and parts of the body below the surface of the skin, as well as for a wide range of clinical procedures where a large-volume Luer-Lok™ syringe is required. The syringes have clear polypropylene barrels with bold graduations, silicone-lubricated plungers and a latex-free stopper with retaining ring to help ensure smooth, controlled movement and to prevent accidental plunger withdrawal.

Bnefits

50 mL large-volume syringe suitable for a wide range of general purpose clinical applications including aspiration, injection and fluid transfer.
BD Luer-Lok™ tip provides a secure, leak-resistant connection to compatible needles, IV devices and accessories, helping reduce the risk of disconnection during use.
Three-piece design (barrel, plunger rod and stopper) with silicone lubrication supports smooth, controlled plunger movement for accurate dosing and comfortable injection.
Clear polypropylene barrel with bold, easy-to-read graduation scale helps improve volume measurement accuracy and facilitates visual inspection of contents and air bubbles.
Retaining ring at the end of the barrel helps prevent accidental plunger rod withdrawal, reducing the risk of fluid spillage and contamination.
Sterile, single-use and EO-sterilised syringes support infection prevention when used with appropriate aseptic technique.
Latex-free stopper and components not intentionally manufactured with DEHP or PVC help reduce the risk of latex and certain plasticiser sensitivities.
Compatible with a wide range of conventional and safety needles, and other Luer-compatible devices, providing versatility and simplifying stock management.

Indications

General purpose aspiration and injection of fluids from vials, ampoules and parts of the body below the surface of the skin (when used with an appropriate needle or device).
Preparation and administration of medications requiring a large-volume syringe with a secure Luer-Lok™ connection.
Use as a large-capacity syringe for IV, irrigation or flushing procedures when a Luer-Lok™ interface is indicated.
Use in infusion and perfusion (including syringe pumps) when compatible with the pump and in accordance with both the syringe technical data sheet and device manufacturer’s instructions.
Use by trained healthcare professionals in hospitals, clinics, theatres, critical care, emergency departments and community healthcare settings where 50 mL Luer-Lok™ syringes are appropriate.

Composition

Barrel: Transparent polypropylene (PP) with printed graduation scale.
Plunger rod: Polypropylene (PP).
Plunger stopper: Synthetic rubber (latex-free) elastomer designed for leak-tight performance.
Lubricant: Medical-grade silicone oil applied to the stopper to ensure smooth plunger movement.
Tip: Concentric BD Luer-Lok™ tip (6% Luer taper with threaded collar) for secure connection to compatible devices.
Packaging: Paperboard carton outer packaging and paper/plastic sterile barrier materials for individual syringes, as per BD Plastipak™ syringes technical data.
Materials of concern: Product line is not made with natural rubber latex and is not intentionally manufactured with DEHP or PVC according to BD Plastipak™/BD general syringe technical data for EMEA.

Formulation

Syringe capacity: 50 mL nominal volume.
Design: 3-piece syringe comprising barrel, plunger rod and elastomeric stopper.
Tip type: Concentric BD Luer-Lok™ tip (threaded Luer connection).
Scale: Large, bold graduations printed on clear barrel for precise volume measurement.
Use configuration: Supplied without needle; compatible with appropriate conventional or safety needles and Luer-compatible devices.
Sterility: Sterile, single-use; sterilised by ethylene oxide (EO).
Latex status: Stopper and other components are latex-free.
Intended users: Trained healthcare professionals; may also be used by patients/caregivers under professional guidance when clinically appropriate.
Typical application: General use syringe as described in BD product data (e.g., BD Luer-Lok™ 50 mL syringe 309653 and related EMEA variants).

Packaging

Each syringe is individually packed in a sterile blister or peel-open pack labelled with product identification, lot number and expiry date.
Box (shelf pack): 60 sterile, single-use BD C/N Luer-Lok™ 50 mL syringes (Medisave SKU SYR566).
Typical case configuration for BD 50 mL Luer-Lok™ syringes: 40 syringes per shelf pack and 160 per case for reference 309653; local distributor outer pack quantities may vary for C/N veterinary/clinical variants.
Sales unit as listed by Medisave: ‘BD C/N Luer Lock Syringes 50ml x 60 – Becton Dickinson’.
Outer cartons printed with BD branding, product code(s), quantity, storage symbols, sterilisation method and regulatory markings.

Usage

Use only if trained in appropriate syringe handling, injection technique and local clinical protocols.
Inspect the sterile pack before use; do not use if the packaging is damaged, opened or if the expiry date has passed.
Open the sterile pack using aseptic technique and remove the syringe, avoiding contamination of the Luer-Lok™ tip and internal components.
Attach a compatible needle or device to the Luer-Lok™ tip by pushing on and twisting clockwise until secure; confirm that the connection is tight before use.
When drawing up fluid, pull back the plunger slowly to aspirate the required volume, checking the graduation marks for accuracy and removing air bubbles per local guidelines.
For injection or administration, expel air from the syringe as required, position the needle or connected device appropriately and depress the plunger at a controlled rate according to clinical instructions.
When used with syringe pumps or other equipment, ensure compatibility, set up the syringe as per device manufacturer instructions and verify correct clamping and orientation.
After use, do not attempt to recap needles unless institutional safety policy specifies a recognised safe technique; instead, activate any needle safety mechanism (if present) and dispose of sharps immediately into an approved sharps container.
Dispose of used syringes and associated needles or devices in accordance with local regulations and institutional infection prevention policies; do not reuse, reprocess or resterilise.
Always consult the BD Plastipak™ / BD Luer-Lok™ syringe technical data sheet and local protocols for full instructions, warnings and precautions.

Contraindications

Do not use if the sterile barrier packaging is open, damaged or shows signs of compromise.
Not intended for long-term indwelling use or implantation.
Do not use for applications requiring a non-Luer connection or where another specific connector type is mandated.
Avoid use with substances known to be incompatible with polypropylene or elastomeric stopper materials; check compatibility data for non-standard solutions.
Do not reuse, reprocess or resterilise; reuse may result in infection, loss of performance and inaccurate dosing.
Although latex-free, do not use in individuals with known hypersensitivity to any component materials if such sensitivities are clinically relevant.
Use only within the recommended pressure and flow limits of the connected system; do not use where extremely high pressures beyond syringe and connection design limits are expected.

Adverse Effects

Potential for medication dosing errors if the syringe graduations are misread or if an inappropriate syringe size is selected.
Risk of fluid leakage or disconnection if the Luer-Lok™ connection is not properly engaged or if incompatible devices are used.
If excessive force is applied on the plunger, there is a risk of patient discomfort, tissue injury or device damage during injection or irrigation.
Risk of contamination and subsequent infection if aseptic technique is not followed or if the syringe is reused contrary to instructions.
Very rare risk of local or systemic reactions related to material sensitivity, though the syringe is latex-free and not intentionally manufactured with DEHP or PVC.
Needlestick and sharps-related injury risk remains when used with needles, particularly if safe handling procedures are not observed.

Storage Conditions

Store in original, unopened packaging until required for use to maintain sterility and protect from contamination.
Keep in a clean, dry environment away from excessive moisture, dust and direct sunlight.
Store at normal room temperatures within the range specified on the outer carton; avoid exposure to extreme temperatures that could damage packaging or syringe materials.
Do not crush or excessively stack cartons in a way that could deform syringes or compromise sterile barrier systems.
Do not use the product after the expiry date printed on the packaging.

Duration

Single-use device intended for one preparation/administration or aspiration episode only. The overall duration of treatment is determined by the prescribed therapy and clinical protocol rather than by the syringe itself.

Onset

Not directly applicable to the syringe; it provides an immediate means of fluid delivery or aspiration once used. Clinical onset of effect depends on the medication or fluid administered and the route of administration.