BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES

    MDR report key: 7500184 · Received May 9, 2018

    Report

    Report Number
    1917413-2018-01367
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    August 18, 2017
    Report Date
    April 30, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903648165
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7033927, MEDICAL DEVICE EXPIRATION DATE: 02/28/2019, DEVICE MANUFACTURE DATE: 02/02/2017. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR (B)(6) WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES HAD "FM AND BROKEN TUBES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343140 BD VACUTAINER® ACD SOLUTION B BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6063544 50382903648165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other