BD Vacutainer Luer Lok Access Device
Becton Dickinson
Medical DeviceSpecimen Collection / IV Access Device (Luer-Lok)
Certifications
- Classified as a sterile, single Use medical device under applicable EU/UK medical device regulations (legacy MDD / MDR) with CE marking for conformity.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- Luer Lok connection designed in accordance with international luer fitting standards for compatibility with female luer and needleless IV ports.
- Subject to BD’s internal quality and safety standards as part of the BD Vacutainer blood and urine specimen collection system.
- Classified as a sterile, single Use medical device under applicable EU/UK medical device regulations (legacy MDD / MDR) with CE marking for conformity.
- Manufactured under an ISO 13485 Compliant quality management system for medical devices.
- Luer Lok connection designed in accordance with international luer fitting standards for compatibility with female luer and needleless IV ports.
- Subject to BD’s internal quality and safety standards as part of the BD Vacutainer blood and urine specimen collection system.
Specimen Collection / IV Access Device (Luer-Lok)
Description
The BD Vacutainer Luer-Lok Access Device is a sterile, single-use sampling device designed for secure and safe specimen collection. It incorporates a threaded Luer-Lok male luer connection and a holder with a pre-attached multiple sample adapter, providing a secure alternative to standard luer slip connectors. The device is specifically designed to access blood or urine directly from catheters, needleless IV sites or Foley catheter sampling ports and transfer the sample into BD Vacutainer tubes in a closed system. The threaded Luer-Lok mechanism helps maintain a closed, leak-resistant connection during sampling, reducing the risk of accidental disconnection, hemolysis, contamination and exposure to blood or body fluids. It is widely used in hospitals and clinical settings to improve the quality and safety of urine and blood specimen collection.
Bnefits
- Provides sterile, secure and safe specimen sampling using a threaded Luer-Lok male luer connection instead of a luer slip device.
- Allows direct access to blood or urine from catheters, Foley ports or compatible needleless IV sites, maintaining a closed system during transfer into Vacutainer tubes.
- Reduces risk of accidental disconnection and leakage compared with non-locking luer interfaces, supporting staff and patient safety.
- Helps reduce sample hemolysis rates when used for blood collection from indwelling catheters compared with traditional syringe or adapter methods.
- Minimises sample manipulation and exposure, improving specimen integrity and reducing risk of contamination or infection.
- Compatible with female luer connections and needleless IV ports designed for Luer-Lok access, integrating into standard infusion and catheter setups.
- Single-use, disposable and sterile, supporting infection prevention and control policies.
- Designed and manufactured by BD under the Vacutainer brand, widely adopted and recognised in clinical laboratories and hospitals.
Indications
- Sterile collection and transfer of venous blood specimens from compatible IV catheters or needleless IV sites into BD Vacutainer blood collection tubes.
- Sterile collection and transfer of urine samples directly from Foley catheter sampling ports into urinalysis or microbiology Vacutainer tubes.
- Use in hospital wards, emergency departments, ICUs, operating theatres and clinical laboratories where closed-system blood or urine collection from vascular or urinary catheters is required.
- Situations where minimising sample manipulation, reducing hemolysis and maintaining a closed collection system are priorities for specimen quality and staff safety.
Composition
- Device body and holder: Medical-grade plastic (e.g. polycarbonate or similar polymer) suitable for single-use medical devices.
- Male Luer-Lok connector: Standard threaded male luer, compatible with female luer connections and needleless IV sites designed for Luer-Lok access.
- Multiple sample adapter: Integrated Vacutainer-compatible adapter designed to accept BD Vacutainer tubes for evacuated specimen collection.
- Latex-free: Components are manufactured without natural rubber latex to reduce risk of latex-related allergic reactions.
- Sterility: Supplied sterile, for single use only.
Formulation
- Device type: Luer-Lok access device with holder and pre-attached multiple sample adapter.
- Connection type: Threaded male Luer-Lok connection for secure attachment to compatible catheter hubs or needleless IV ports.
- Function: Enables closed-system transfer of blood or urine into evacuated BD Vacutainer tubes.
- Use: Single-use, disposable medical device (do not reuse or re-sterilise).
- Compatibility: Female luer connections and needleless IV sites designed for Luer-Lok access; BD Vacutainer blood and urine collection tubes.
Packaging
- Primary packaging: Individually sterile-packed access device (pouch or blister) to maintain sterility until point of use.
- Standard box configuration from manufacturer: Boxes containing approximately 198–200 devices (e.g. Reference 364902 or 36490200), often packed as 4 inner packs of 50 devices depending on region.
- Label information: Product name, reference number (REF 364902 / 36490200), lot number, expiry date, sterility symbol, single-use symbol and manufacturer details.
- Retailers may offer single devices or smaller quantities by splitting manufacturer boxes, while maintaining original sterile individual packaging.
Usage
- Confirm that the sterile packaging is intact and check the expiry date before use; do not use if packaging is damaged or expired.
- Open the sterile pack using aseptic technique immediately prior to use.
- Connect the threaded male Luer-Lok end of the device securely to the female luer or needleless port of the compatible IV catheter, urinary catheter (Foley sampling port) or other access site, turning until tight to ensure a secure, leak-resistant connection.
- Insert the appropriate BD Vacutainer tube into the multiple sample adapter end of the device, pushing the tube onto the internal needle to allow vacuum-based specimen draw.
- Allow the required volume of blood or urine to fill the tube according to standard Vacutainer tube fill guidelines; follow recommended order of draw for blood tubes where applicable.
- If multiple tubes are required, remove the filled tube while maintaining the device connection to the access site and insert the next tube into the adapter, repeating until all specimens are collected.
- After collection, remove the final tube, detach the device from the catheter or port and dispose of the device immediately in an appropriate sharps or biohazard container according to local policy.
- Do not attempt to flush, re-use or re-sterilise the device; it is designed strictly for single use.
- Follow local infection prevention and specimen handling protocols at all times when using the device.
Contraindications
- Do not use if the sterile package is opened, damaged or compromised prior to intended use, as sterility cannot be guaranteed.
- Not for reuse; do not re-process, re-sterilise or re-use the device, as this may compromise performance and increase risk of infection or device failure.
- Do not use with non-compatible connectors or ports that do not conform to Luer-Lok standards, as this may result in improper connection or leakage.
- Do not use in patients or situations where a closed specimen-collection system via catheter or Foley port is contraindicated according to clinical judgement.
- Avoid use if visible defects such as cracks, deformation or missing components are present in the device.
Adverse Effects
- Potential for device disconnection or leakage if not properly threaded and tightened onto the luer connection, which may lead to sample loss or exposure to blood or urine.
- Risk of hemolysis or compromised sample quality if specimen collection protocols are not followed (e.g. excessive pressure, improper tube order, drawing from inappropriate sites).
- Risk of infection or cross-contamination if aseptic technique and single-use instructions are not adhered to.
- As with any blood or urine collection device, there is a general risk of exposure to biohazardous material if the device is mishandled or disposed of improperly.
- Very rare device-specific mechanical issues (e.g. internal needle or adapter damage) may prevent proper tube filling and require device replacement.
Storage Conditions
- Store in a clean, dry environment at room temperature, within the temperature range specified on the packaging.
- Keep in original packaging until use to protect from contamination and maintain sterility.
- Protect from excessive heat, moisture and direct sunlight, and keep away from sources of physical damage or crushing.
- Do not use after the expiry date printed on the packaging.
- Keep out of reach of children and unauthorised personnel.
Duration
Not applicable. This is a single-use access device used for the duration of a single specimen collection event and discarded immediately after use.
Onset
Not applicable. The device provides immediate functionality for specimen sampling once connected and used according to protocol.
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