BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 19652374 · Received July 1, 2024

    Report

    Report Number
    8041187-2024-00054
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903017479
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INVESTIGATION SUMMARY: "MATERIAL #: 301747 LOT/BATCH #: 4023994 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE 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 SLEEVE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE, THE SLEEVE COVERING THE NON-PATIENT CANNULA LEAKED BLOOD AFTER THE FIRST COLLECTION TUBE WAS DRAWN. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822057 BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 4023994 30382903017479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown