BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 19057003 · Received April 7, 2024

    Report

    Report Number
    8041187-2024-00033
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    JKA
    UDI-DI
    30382903017462
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 301746. LOT/BATCH #: 3240846. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR LEAKAGE WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL, (B)(6) (UNIVERSITY. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THAT THERE THERE IS BLOOD LEAKAGE AT THE TAIL END OF THE RUBBER PLUG. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THAT THERE THERE IS BLOOD LEAKAGE AT THE TAIL END OF THE RUBBER PLUG. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084258 BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 3240846 30382903017462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown