BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER

    MDR report key: 7068018 · Received November 29, 2017

    Report

    Report Number
    2243072-2017-00346
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    May 5, 2016
    Report Date
    November 22, 2017
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    00382903648801
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LOT #6042675 WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER HAD BLOOD LEAKAGE AT THE CONNECTION OF THE HUB. RIGHT AT THE BASE OF THE HUB WHERE THE RED TIP SHOULD BE SEALED IS WHERE IT OCCURRED. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848964 BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER BLOOD COLLECTION TUBE JKA BD CARIBE LTD. 6042675 00382903648801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other