BD Integra™ 3 mL Safety Syringe with Detachable Retracting BD Needle 21G x 1.5
Becton Dickinson
Medical device – safety hypodermic syringe with needleRetracting safety syringe with detachable hypodermic needle, 3 mL, 21G x 1.5 in
Certifications
- CE Marked as a safety hypodermic syringe with needle under applicable European and UK medical device regulations (Class IIa).
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Biocompatibility of materials evaluated in accordance with ISO 10993 series standards for devices with temporary blood and tissue contact.
- Sterilisation process validated to an appropriate sterility assurance level in line with ISO and EN standards for terminally sterilised single Use medical devices.
- Design and performance aligned with relevant ISO/EN standards for hypodermic needles and syringes, including volumetric accuracy and connection performance.
- Latex Free design consistent with BD labelling and regulatory guidance for minimising exposure to natural rubber latex.
- CE Marked as a safety hypodermic syringe with needle under applicable European and UK medical device regulations (Class IIa).
- Manufactured under an ISO 13485 Certified quality management system for medical devices.
- Biocompatibility of materials evaluated in accordance with ISO 10993 series standards for devices with temporary blood and tissue contact.
- Sterilisation process validated to an appropriate sterility assurance level in line with ISO and EN standards for terminally sterilised single Use medical devices.
- Design and performance aligned with relevant ISO/EN standards for hypodermic needles and syringes, including volumetric accuracy and connection performance.
- Latex Free design consistent with BD labelling and regulatory guidance for minimising exposure to natural rubber latex.
Retracting safety syringe with detachable hypodermic needle, 3 mL, 21G x 1.5 in
Description
The BD Integra™ 3 mL Safety Syringe with Detachable Retracting BD Needle 21G x 1.5\ is a sterile, single-use, spring-based retracting safety syringe designed to help reduce the risk of needlestick injury and medication waste. The system consists of a 3 mL hypodermic syringe with BD Tru-Lok™ removable tip and a detachable BD PrecisionGlide™ hypodermic needle (21 gauge, 1½ inch, green hub). After injection, the clinician activates the spring-based safety mechanism by fully depressing the plunger until two tactile clicks are felt; the needle then retracts automatically into the syringe barrel and locks in place, eliminating exposure to the used needle. The BD Integra™ syringe features very low waste space (approximately 0.026 mL) compared with conventional luer lock syringe-and-needle combinations, helping to minimise medication loss and reduce cost, especially with high-value drugs. The system is intended for intramuscular and subcutaneous administration of a wide range of medications, providing secure Tru-Lok™ connection, reliable dose delivery and a controlled, simple activation sequence.
Bnefits
- Spring-based retracting safety mechanism that pulls the used needle back into the barrel and locks it after activation, significantly reducing the risk of accidental needlestick injuries.
- Very low waste space (around 0.026 mL) compared with traditional luer-lock syringe/needle systems, helping reduce medication loss and associated costs, particularly for expensive injectable drugs.
- BD Tru-Lok™ detachable needle connection provides a secure, non-luer-thread design that minimises dead space at the hub while allowing needle changes for aspiration and administration if required.
- Gives clinicians a choice to activate the safety mechanism either before or after withdrawing the needle from the patient while still ensuring complete dose delivery prior to needle retraction.
- Detachable BD PrecisionGlide™ 21G x 1.5" hypodermic needle offers sharp bevel geometry and lubrication to support smooth tissue penetration and patient comfort during intramuscular or deep subcutaneous injection.
- Clear, graduated 3 mL syringe barrel with bold scale markings allows accurate dose measurement and easy visual inspection of fluid and air bubbles.
- Standard 3 mL volume and 21G x 1.5" configuration covers a wide range of IM and SC injection indications in adult patients, supporting versatility in clinical practice.
- Sterile, single-use, latex-free device helps support infection prevention and minimises the risk of latex-related hypersensitivity reactions.
- Simple, intuitive activation sequence with two tactile clicks and visible needle retraction helps users verify that the safety mechanism is fully engaged.
- Designed as a complete, integrated safety system from a single manufacturer, supporting consistent performance, regulatory compliance and training.
Indications
- Intramuscular administration of vaccines, analgesics, antibiotics and other medications where a 3 mL syringe with a 21G x 1.5" needle is clinically appropriate.
- Subcutaneous or deep subcutaneous injections when a 21G needle and 3 mL capacity are suitable in line with local guidelines.
- Situations requiring a safety-engineered hypodermic syringe to reduce needlestick injuries and blood exposure risk to healthcare workers.
- Use in hospital, clinic, community care and outpatient settings for routine parenteral injections in adult and appropriate adolescent patients.
Composition
- Barrel: Transparent medical-grade polypropylene with printed 3 mL graduation scale (mL markings).
- Plunger rod: Polypropylene or polystyrene plunger rod designed with thumb pad for controlled actuation.
- Plunger stopper (piston): Synthetic rubber (latex-free) elastomer forming a tight seal with the inner barrel surface.
- Needle cannula: Stainless steel hypodermic tubing, 21 gauge, 1.5 inch (38 mm) length with multi-faceted bevel tip.
- Needle hub: Green BD Tru-Lok™ detachable hub made of medical-grade polymer, designed for secure low dead space connection to the syringe tip.
- Needle lubricant: Medical-grade silicone oil applied to the cannula to reduce penetration force and improve comfort.
- Retracting mechanism: Internal spring-based mechanism integrated into the syringe that retracts the needle into the barrel upon full plunger depression and activation.
- Tip connection: BD Tru-Lok™ removable tip design providing a secure, non-luer-thread connection with reduced dead space versus standard luer-lock interfaces.
- Protective needle shield: Rigid plastic cap (colour-matched to gauge) covering the needle before use to maintain sterility.
- Materials status: Latex-free; natural rubber latex is not intentionally used in device components or primary packaging.
Formulation
- Device type: Safety hypodermic syringe with detachable, spring-based retracting needle.
- Syringe volume: 3 mL nominal fill volume.
- Needle size: 21G (0.8 mm outer diameter) x 1.5 inch (38 mm) hypodermic needle.
- Hub colour: Green needle hub indicating 21G gauge in accordance with standard colour coding.
- Connection type: BD Tru-Lok™ retracting, detachable needle connection with low waste space design.
- Waste space: Approximately 0.026 mL residual volume in syringe-and-needle system (low dead space).
- Needle type: BD PrecisionGlide™ hypodermic needle compatible with intramuscular and subcutaneous injection techniques.
- Safety mechanism: Spring-based internal retraction activated by fully depressing the plunger until two clicks are felt, after which the needle is retracted into and locked within the barrel.
- Sterility: Terminally sterilised single-use device, supplied sterile for one-time use only.
- Shelf life: Typically 5 years from date of sterilisation when stored as per manufacturer instructions.
Packaging
- Primary packaging: Individual sterile blister or peel-pack containing one 3 mL BD Integra™ syringe pre-assembled with a detachable BD PrecisionGlide™ needle (21G x 1.5").
- Box configuration: 100 syringes per box (soft pack / box of 100).
- Case configuration: 4 boxes per case (400 syringes per case), corresponding to the x400 Medisave listing.
- Labelling: Each unit and outer carton labelled with product name, catalogue number (305274), volume (3 mL), needle size (21G x 1.5"), lot number, expiry date, sterility symbol, single-use symbol and regulatory markings (including CE).
- Protection: Packaging designed to maintain sterility and protect the syringe and needle from mechanical damage, moisture and contamination throughout the shelf life.
Usage
- Check the packaging for integrity and expiry date before use; do not use if the sterile blister is damaged, opened or expired.
- Perform hand hygiene and don appropriate personal protective equipment in accordance with institutional protocols.
- If the needle is supplied separately, attach the BD Integra™ retracting needle to the BD Integra™ syringe by pushing the hub onto the Tru-Lok™ tip and twisting clockwise until secure. If pre-attached, ensure the needle hub is fully tightened.
- Remove the protective needle shield by pulling it straight off without twisting or bending the needle.
- Draw up medication from a vial or ampoule in accordance with established protocols, taking care to maintain aseptic technique and to eliminate air bubbles from the syringe.
- Adjust the plunger to the prescribed dose using the 3 mL graduation scale to ensure accurate volume measurement.
- Select an appropriate injection site and prepare the skin with a suitable antiseptic, allowing it to dry according to local infection prevention guidance.
- Insert the needle into the patient using the appropriate angle and depth for the intended route (typically 90° for intramuscular injection, 45–90° for subcutaneous injection depending on patient factors and drug requirements).
- Inject the medication at a controlled rate, fully depressing the plunger to deliver the complete dose.
- To activate the safety mechanism, continue to press the plunger firmly until two tactile clicks are felt; the spring-based system will retract the needle into the barrel. Activation may be performed either while the needle is still in the tissue (per protocol) or immediately after withdrawal, provided the full dose has been delivered.
- Confirm that the needle has fully retracted and is no longer visible outside the barrel; the plunger should be recessed and locked in the activated position.
- Immediately dispose of the entire device in an approved sharps container; do not attempt to reuse, disassemble or override the safety mechanism.
- Do not attempt to recap the needle at any time. Follow local sharps safety and waste disposal policies.
- Document the medication administration in the patient record in line with institutional procedures.
Contraindications
- Do not use in patients with known or suspected hypersensitivity to any of the device materials (e.g., stainless steel, synthetic rubber, polyolefin components) when such sensitivities have been clinically established.
- Not indicated for intrathecal, intraocular, intra-arterial or epidural injection unless explicitly validated and specified by the medicinal product and institutional guidelines.
- Do not use if the sterile package is damaged, opened, contaminated or past its labelled expiry date.
- Do not reuse, reprocess or resterilise; reuse may result in infection transmission, loss of functionality or failure of the safety mechanism.
- Do not attempt to deactivate, obstruct or modify the retracting mechanism; any alteration can compromise safety performance.
- Do not use for high-pressure injection applications beyond the device’s specified pressure tolerances.
- Avoid use with medications that are not compatible with the materials of construction (e.g., certain solvents) if such incompatibilities are identified by the drug or device manufacturer.
Adverse Effects
- Local injection-site reactions such as pain, transient burning, erythema, bruising, bleeding or swelling, primarily related to injection technique and medication rather than the syringe design.
- Rare occurrence of local infection or abscess at the injection site if aseptic technique is not followed or if the injection site is contaminated.
- Potential for tissue trauma, nerve irritation or vessel injury if the needle is inserted incorrectly or at an inappropriate site.
- Systemic adverse reactions or hypersensitivity responses related to the injected medication (e.g., allergic reactions, anaphylaxis, systemic side effects), attributable to the drug rather than to the syringe.
- Device-related issues such as incomplete needle retraction or leakage can occur rarely, particularly if the device is mishandled or not activated correctly; such events should be managed according to institutional incident reporting and patient safety protocols.
- Needlestick injuries are substantially reduced by the integrated safety design, but may still occur if the device is not used in accordance with instructions or if sharps-handling protocols are not followed.
Storage Conditions
- Store the syringes in their original packaging in a clean, dry environment.
- Maintain at standard room temperature conditions within the range specified on the product labelling; avoid excessive heat, freezing temperatures and high humidity.
- Protect from direct sunlight and sources of ozone or chemicals that may degrade plastic or elastomer components.
- Do not expose the sterile packaging to crushing, puncture or other mechanical damage that could compromise sterility.
- Keep out of the reach of children and unauthorised persons.
- Do not use the product after the expiry date indicated on the packaging.
Duration
Single-use device intended for one episode of medication preparation and injection only; it is not intended for extended or repeated use. The duration of patient treatment is determined by the specific medicinal product and clinical regimen rather than the syringe.
Onset
Not applicable to the device itself. The onset, peak and duration of therapeutic effect depend on the pharmacological properties of the injected medication, dose, route of administration and patient-specific factors, not on the BD Integra\u2122 syringe.
