BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 7485398 · Received May 3, 2018

    Report

    Report Number
    1917413-2018-01240
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    January 3, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6253709; MEDICAL DEVICE EXPIRATION DATE: 01/31/2018; DEVICE MANUFACTURE DATE:09/09/2016; MEDICAL DEVICE LOT #: 6253710; MEDICAL DEVICE EXPIRATION DATE:01/31/2018; DEVICE MANUFACTURE DATE:09/09/2016. " RESULT: 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 95042 WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES WERE HAVING ERRONEOUS RESULT , NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325550 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6253706 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other