BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 7466515 · Received April 26, 2018

    Report

    Report Number
    1917413-2018-01035
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    January 6, 2017
    Report Date
    April 21, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6173942, MEDICAL DEVICE EXPIRATION DATE: 09/30/2017, DEVICE MANUFACTURE DATE: 06/21/2016. " BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LABEL ERRORS WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES CONTAINED LABELS THAT WEREN'T PRINTED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308773 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6216523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other