BD Plastipak™ 10 ml Hypodermic Syringe, 3 Piece with BD Microlance™ 3 Needle 21G x 40 mm

Becton Dickinson

Medical disposables

Hypodermic syringes with needle

Conforms to EU Medical Devices Directive 93/42/EEC; syringes with needle (including ref. 308027) classified as Class IIa medical devices.
CE Marked BD Plastipak™ syringe range, with conformity assessment performed by a notified body (e.g. Agencia Española de Medicamentos y Productos Sanitarios, NB 0318) under relevant annexes.
Syringe materials free from natural rubber latex, PVC and phthalates according to BD Plastipak™ technical data.
Manufactured under a certified quality management system compliant with ISO 13485 for medical devices.
Luer and Luer Lok™ connections compliant with ISO 594 1 and ISO 594 2 (or superseding standards for 6% luer conical fittings).
BD Microlance™ 3 hypodermic needle component described as sterile, single Use, latex Free and meeting BD’s internal and international performance standards for thin Wall, regular Bevel hypodermic needles.

Conforms to EU Medical Devices Directive 93/42/EEC; syringes with needle (including ref. 308027) classified as Class IIa medical devices.
CE Marked BD Plastipak™ syringe range, with conformity assessment performed by a notified body (e.g. Agencia Española de Medicamentos y Productos Sanitarios, NB 0318) under relevant annexes.
Syringe materials free from natural rubber latex, PVC and phthalates according to BD Plastipak™ technical data.
Manufactured under a certified quality management system compliant with ISO 13485 for medical devices.
Luer and Luer Lok™ connections compliant with ISO 594 1 and ISO 594 2 (or superseding standards for 6% luer conical fittings).
BD Microlance™ 3 hypodermic needle component described as sterile, single Use, latex Free and meeting BD’s internal and international performance standards for thin Wall, regular Bevel hypodermic needles.

Hypodermic syringes with needle

Description

Sterile, single-use, 3-piece 10 ml BD Plastipak™ hypodermic syringe supplied pre-mounted with a BD Microlance™ 3 hypodermic needle 21G x 40 mm (green) in a compact \syringe plus needle\ unit. The syringe features a clear polypropylene barrel with bold graduations, a smooth silicone-lubricated plunger and a synthetic isoprene latex-free gasket to ensure leak-free performance even under high pressure. The attached BD Microlance™ 3 needle is a stainless-steel, regular-bevel, thin-wall green 21G needle (0.8 x 40 mm / 1½\) individually sterile, suitable for a wide range of hypodermic injections. The combined unit simplifies injection technique by reducing handling steps while providing all the benefits of BD Plastipak™ syringes and BD Microlance™ 3 needles in a single pack of 100.

Bnefits

Three-piece syringe construction (barrel, plunger rod and gasket) provides reliable leak-free performance, even under high injection pressures.
Clear, transparent barrel with bold, easy-to-read graduation marks supports accurate dose measurement and visual control of syringe contents.
Special silicone lubrication on the barrel and gasket ensures smooth, even plunger travel for controlled aspiration and injection.
Latex-free synthetic isoprene gasket eliminates the risk of natural rubber latex allergy from the syringe components.
Pre-mounted BD Microlance™ 3 21G x 40 mm (0.8 x 40 mm) needle provides a sharp, regular bevel and thin wall for comfortable, efficient injection.
Compact syringe-plus-needle unit reduces handling steps, simplifies injection workflow and helps lower overall procedure costs.
Standard Luer tip (luer slip/concentric) compatible with a wide range of luer-connect devices when the needle is removed, if required.
Sterile, single-use design helps minimise risk of cross-contamination and infection.
Free from PVC and phthalates according to BD Plastipak™ technical documentation, supporting compatibility with a wide range of drugs.

Indications

General hypodermic administration of pharmaceuticals by qualified healthcare professionals.
Intramuscular (IM), subcutaneous (SC) and other approved hypodermic injection routes using a 21G x 40 mm needle when clinically appropriate.
Aspiration and injection of fluids in hospital, clinic, dental, primary care and medical aesthetics settings.
Procedures requiring a 10 ml syringe volume combined with a 21G hypodermic needle, including reconstitution and administration of injectable medications and vaccines, where suitable.

Composition

Syringe barrel: Polypropylene (latex-free), transparent.
Plunger rod: Polypropylene with ergonomically shaped thumb press.
Plunger gasket (piston seal): Synthetic isoprene rubber (latex-free).
Lubrication: Medical-grade silicone oil on the inner barrel and gasket to ensure smooth plunger movement.
Needle cannula: Stainless steel (AISI 304) BD Microlance™ 3 hypodermic needle.
Needle hub and protective cap: Polypropylene (colour-coded green for 21G).
Adhesive for needle bonding: Epoxy resin.
Printing: Graduated scale and markings in ink suitable for medical use.
Materials explicitly free from: Natural rubber latex, PVC and phthalates, according to BD Plastipak™ technical data.

Formulation

Device type: 3-piece hypodermic syringe with pre-mounted hypodermic needle.
Syringe capacity: 10 ml nominal volume.
Graduation: Typically 0.5 ml scale (10 ml scale length approx. 61.5 mm), allowing accurate dosing.
Tip type: Luer tip (concentric, luer slip configuration) compatible with standard luer connections.
Needle: BD Microlance™ 3 hypodermic needle, 21G x 40 mm (0.8 x 40 mm), colour-coded green, thin wall, regular bevel.
Use: Sterile, single-use medical device for hypodermic injection and aspiration.
Device class (EU): Syringes with needle classified as Class IIa medical devices under Directive 93/42/EEC.

Packaging

Primary packaging: Each syringe-plus-needle unit is individually sterile-packed (blister or peel-pack) for single use.
Box configuration: 100 pre-mounted syringe-and-needle units per box for reference 308027.
Shipping carton: 400 units per outer carton (4 boxes of 100) according to BD Plastipak™ technical data.
Pallet configuration: 12,000 units per pallet (as per manufacturer’s packaging specification for ref. 308027).
Labelling: Box and outer carton labelled with BD Plastipak™ branding, product description, reference code 308027, needle size 21G x 1½" (0.8 x 40 mm), sterility symbol, lot number and expiry date.

Usage

Check the packaging for integrity and expiry date before use; do not use if packaging is damaged or the product is expired.
Open the individual sterile pack using aseptic technique immediately before the procedure.
If required, draw air into the syringe to equal the volume of medication to be withdrawn (according to local protocol).
Insert the needle into the vial or ampoule, inject air if appropriate, and aspirate the prescribed volume of medication using the graduation marks on the barrel.
Remove any visible air bubbles by gently tapping the barrel and slowly expelling air until the correct dose is set.
Prepare the injection site according to standard skin antisepsis protocols.
Insert the needle at the correct angle and depth for the chosen route of administration (e.g. IM, SC) and inject the medication slowly as per clinical guidance.
Withdraw the needle, apply appropriate post-injection care (e.g. gauze and pressure), and dispose of the used syringe and needle immediately in an approved sharps container.
Do not recap the needle after use and do not attempt to reuse, clean or resterilise the syringe or needle.

Contraindications

Do not use for any purpose other than hypodermic injection or aspiration by trained healthcare professionals.
Do not use if sterile packaging is damaged, opened or if the product is past its expiry date.
Not suitable for patients with known hypersensitivity to any device component if such sensitivity is clinically relevant (e.g. rare sensitivities to silicone oils or certain plastics).
Do not reuse or resterilise; reuse can significantly increase the risk of infection, cross-contamination and device failure.
Do not use for intrathecal, intra-ocular or other specialised routes unless specifically approved by relevant clinical guidelines for this needle size and syringe type.

Adverse Effects

No device-specific adverse effects are expected when used correctly; potential adverse events are those generally associated with hypodermic injections (e.g. pain, bruising, minor bleeding at the injection site).
Possible local reactions include redness, swelling or induration at the injection site.
Incorrect technique or inappropriate route of administration can lead to tissue injury or nerve damage.
Reuse or non-sterile handling of the device can result in serious infection or transmission of blood-borne pathogens.
Needlestick injuries to staff may occur if sharps safety procedures are not followed.

Storage Conditions

Store in a clean, dry environment at ambient room temperature, typically between 15°C and 25°C, as indicated in BD technical documentation.
Protect from direct sunlight, excessive heat, moisture and physical damage.
Keep in original packaging until use to maintain sterility and protect from contamination.
Do not freeze or expose to conditions that could deform the plastic components or compromise packaging integrity.

Duration

Not applicable as a medicinal treatment. The device is intended for transient, single-use during a single injection or aspiration procedure and must be discarded immediately afterwards.

Onset

Not applicable as a pharmacological parameter. The device provides immediate functional benefit by enabling accurate aspiration and injection as soon as it is prepared and used according to clinical protocol.