BD Eclipse Hypodermic Needle Range

Becton Dickinson

Medical device – needle and syringe combination

Safety hypodermic needle with pivoting shield and 3 mL Luer-Lok\u2122 syringe

CE Marked medical device under the European medical device regulatory framework for hypodermic needles and syringes.
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Designed to comply with relevant ISO standards for sterile hypodermic needles (e.g. ISO 7864) and syringes for manual use (e.g. ISO 7886 1), including requirements for performance, leak tightness and graduation accuracy.
Ethylene oxide (EO) sterilisation validated according to EN ISO 11135 and related standards for sterilisation of healthcare products.
Biocompatibility evaluated in accordance with ISO 10993 series for materials in contact with blood and body fluids for limited exposure.
Packaging and sterile barrier systems validated to meet EN ISO 11607 requirements for terminally sterilised medical devices.
Part of the BD safety hypodermic portfolio supporting occupational safety and compliance with needlestick injury prevention directives and guidelines.
Latex Free labelling in line with regulatory and industry guidance on minimising latex Related allergic reactions.

CE Marked medical device under the European medical device regulatory framework for hypodermic needles and syringes.
Manufactured under an ISO 13485 Certified quality management system for medical devices.
Designed to comply with relevant ISO standards for sterile hypodermic needles (e.g. ISO 7864) and syringes for manual use (e.g. ISO 7886 1), including requirements for performance, leak tightness and graduation accuracy.
Ethylene oxide (EO) sterilisation validated according to EN ISO 11135 and related standards for sterilisation of healthcare products.
Biocompatibility evaluated in accordance with ISO 10993 series for materials in contact with blood and body fluids for limited exposure.
Packaging and sterile barrier systems validated to meet EN ISO 11607 requirements for terminally sterilised medical devices.
Part of the BD safety hypodermic portfolio supporting occupational safety and compliance with needlestick injury prevention directives and guidelines.
Latex Free labelling in line with regulatory and industry guidance on minimising latex Related allergic reactions.

Safety hypodermic needle with pivoting shield and 3 mL Luer-Lok\u2122 syringe

Description

The BD Eclipse™ Needle 21 G x 1 in. with detachable 3 mL BD Luer-Lok™ Syringe (REF 305779) is a sterile, single-use, safety-engineered injection device that combines a 21-gauge, 1-inch hypodermic needle with a 3 mL BD Luer-Lok™ syringe. The needle features a pivoting, hinged safety shield designed for single-handed activation immediately after injection, helping to reduce the risk of needlestick injuries. The bevel-oriented needle allows for low-angle injections, while BD PrecisionGlide™ needle technology supports smooth penetration. The attached 3 mL BD Luer-Lok™ syringe provides a clear barrel with bold scale markings, a tapered plunger rod for ease of aspiration, a positive plunger-rod stop, and a threaded Luer-Lok™ tip for secure connection. The device is intended for general use injections and blood collection applications and is supplied sterile in boxes of 50 units (300 per case).

Bnefits

Integrated safety-engineered design that combines a hypodermic needle with a 3 mL BD Luer-Lok™ syringe for general injection and blood collection use.
Pivoting, hinged safety shield enables single-handed activation immediately after injection, reducing the risk of accidental needlestick injuries.
Bevel-oriented needle aligned with the safety cover facilitates low-angle injections for improved injection technique and patient comfort.
BD PrecisionGlide™ needle technology helps provide smooth needle penetration and consistent performance during injections.
3 mL BD Luer-Lok™ syringe features a clear barrel with bold scale markings and 0.1 mL graduation to support accurate dosing.
Tapered plunger rod and positive plunger-rod stop improve control, ease aspiration and help prevent accidental plunger pullout.
Luer-Lok™ threaded tip provides a secure connection between the syringe and needle, reducing the risk of disconnection or leakage under pressure.
Latex-free labelling and single-use, sterile packaging support infection prevention and minimise the risk of latex-related reactions.
Needle-based safety design allows clinicians to standardise on one safety technology for both injection and blood collection applications, supporting SKU reduction.
Supplied as a complete needle–syringe system in convenient cartons of 50 units, simplifying stock management in clinical settings.

Indications

General purpose intramuscular, subcutaneous and intradermal injections of approved medicinal products when used with appropriate technique.
Venous blood collection and other blood sampling procedures when used according to institutional protocols and local regulations.
Aspiration and injection of fluids for diagnostic or therapeutic purposes in hospital, primary care, outpatient, emergency and ambulatory settings.
Use in clinical areas where safety-engineered needles are required or recommended to reduce occupational exposure to bloodborne pathogens.
Suitable for adult and paediatric patients where a 21 G x 1 in. needle and 3 mL syringe are clinically appropriate.

Composition

Needle cannula: Stainless steel hypodermic tubing, 21 gauge, thin wall, regular bevel.
Needle hub and safety shield: Medical-grade plastic (e.g. polypropylene or equivalent) with integrated pivoting, hinged safety mechanism.
Syringe barrel: Clear medical-grade polypropylene with printed black graduation scale.
Syringe plunger rod: Medical-grade polypropylene with tapered design and positive plunger stop.
Plunger stopper: Latex-free synthetic elastomer rubber, designed to ensure a tight seal and smooth plunger movement.
Lubricant: Medical-grade silicone oil or equivalent applied to reduce sliding friction between stopper and barrel.
Connector: BD Luer-Lok™ threaded tip integrated into the syringe barrel for secure needle attachment.
Primary packaging: Individual sterile blister or peel pack providing a sterile barrier for the needle–syringe combination.
Secondary packaging: Printed cardboard shelf box containing 50 individually packaged units; shipping case containing 300 units (6 shelf boxes).

Formulation

Fill volume / syringe capacity: 3 mL.
Syringe tip type: BD Luer-Lok™ (threaded Luer connection).
Needle gauge: 21 G.
Needle length: 1 in. (25 mm).
Needle type: Hypodermic, thin wall, regular bevel.
Safety feature: Hinged, pivoting safety shield for single-handed activation that fully covers the needle after use.
Typical application: General use injections and blood collection.
Disposability: Single-use, disposable, sterile product.
Packaging configuration: 50 units per box; 300 units per case.
UDI / GTIN: GTIN (Each) 00382903057795; GTIN (Shelf pack, 50/box) 30382903057796; GTIN (Case, 300/case) 50382903057790.

Packaging

Individually sterile-packed BD Eclipse™ Needle 21 G x 1 in. with detachable 3 mL BD Luer-Lok™ Syringe per unit.
Shelf box contains 50 individually packaged needle–syringe combinations (50/box).
Shipping case contains 6 shelf boxes, for a total of 300 units per case (300/case).
Approximate shelf box dimensions: 28 cm length × 14.5 cm width × 12 cm height.
Approximate case dimensions: 43.942 cm length × 28.702 cm width × 24.384 cm height.
Outer cartons labelled with BD branding, product name, catalogue number (305779), GTINs, needle gauge and length, syringe volume, sterility method, lot number, and expiry date.
Packaging clearly labelled as sterile, single-use and latex-free.

Usage

Verify that the product is within its expiry date and that the sterile package is intact; do not use if the packaging is damaged, opened or contaminated.
Open the sterile pack aseptically and remove the syringe–needle combination, taking care not to touch the needle or inner surfaces.
If required by local protocol, draw air into the syringe prior to accessing vials or ampoules, then insert the needle and aspirate the medicinal product to the prescribed volume using the 0.1 mL graduation scale for accuracy.
Remove any visible air bubbles according to institutional procedures by gently tapping the syringe and expelling air while keeping the needle tip oriented upward.
Prepare the injection site and patient in accordance with standard clinical guidelines for the intended route of administration (e.g. intramuscular, subcutaneous, intradermal).
Insert the needle using the appropriate angle and depth for the selected route, stabilising the syringe using the finger flanges and ensuring a secure Luer-Lok™ connection.
Administer the medication by depressing the plunger at a controlled rate; avoid excessive force to reduce patient discomfort and risk of needle movement.
Immediately after completing the injection and before withdrawing the needle from the patient (or immediately after removal, according to local protocol), activate the BD Eclipse™ safety shield using a single-finger stroke on the safety arm until an audible or tactile click confirms full engagement over the needle.
Visually confirm that the safety shield fully covers and locks over the needle tip; do not attempt to re-expose or reuse the needle once the shield is activated.
Dispose of the entire needle–syringe unit promptly in an approved sharps container in accordance with local, national and institutional sharps disposal policies.
Do not reuse, reprocess, or resterilise the device; it is designed and validated for single-patient, single-procedure use only.
Refer to BD’s electronic Instructions for Use (eIFUs) and institutional policies for additional detailed guidance on safe use and handling.

Contraindications

Do not use if the sterile packaging is open, damaged or compromised, or if the product is past its expiry date.
Do not reuse, reprocess or resterilise; reuse can lead to loss of sterility, infection, needlestick injury or device malfunction.
Not intended for use in patients with known hypersensitivity to any of the device materials if clinically relevant, although components are latex-free and designed to be biocompatible.
Do not use for high-pressure injection applications beyond the syringe and needle’s rated capability as this may cause leakage, disconnection or breakage.
Do not attempt to bend, cut, recap or otherwise manually manipulate the needle before or after use; rely on the integrated safety shield for post-use protection.
Do not use if the needle is visibly bent, damaged, corroded or if the syringe barrel, plunger or Luer-Lok™ tip shows cracks or deformation.

Adverse Effects

Risk of local site reactions such as pain, redness, bruising or swelling associated with needle insertion and the injected medication.
Potential bleeding or haematoma at the puncture site, particularly in patients with coagulation disorders or on anticoagulant therapy.
Risk of infection or abscess formation at the injection site if aseptic technique is not strictly followed.
Possible nerve or tissue injury if the needle is inserted improperly or into inappropriate anatomical locations.
Systemic adverse effects related to the drug or solution administered (e.g. allergic reactions, anaphylaxis), which are attributable to the medication rather than the device.
Occupational exposure risks to healthcare workers, including needlestick injuries and bloodborne pathogen transmission, if the safety shield is not activated correctly or sharps are mishandled.
Very rare risk of hypersensitivity to materials used in the syringe or needle assembly, despite the device being latex-free and designed for biocompatibility.

Storage Conditions

Store in a clean, dry environment at ambient room temperature within the range specified on the packaging; avoid extremes of heat and cold.
Keep products in their original cartons until point of use to protect from light, dust, moisture and physical damage.
Do not expose packaging to direct sunlight, excessive humidity or sources of ozone or chemicals that may degrade plastics or elastomers.
Avoid crushing, bending or stacking heavy loads on cartons to maintain integrity of the needle–syringe assemblies and sterile barrier.
Observe any specific storage symbols and instructions provided on the BD packaging, including the labelled expiry date.
Do not use the device after the expiry date printed on the unit pack and outer carton.

Duration

Single-use device intended for one episode of medication preparation, injection and/or blood collection; overall treatment duration is determined by the therapeutic regimen rather than by the device, which must be discarded immediately after a single use.

Onset

Not directly applicable to the device; clinical onset of effect depends on the medicinal product, dosage, route of administration and patient factors, not on the needle\u2013syringe combination itself.

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Consentz Hub

BD Eclipse Hypodermic Needle Range

Description

Bnefits

Indications

Composition

Formulation

Packaging

Usage

Contraindications

Adverse Effects

Storage Conditions

Duration

Onset

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