BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

    MDR report key: 7507862 · Received May 11, 2018

    Report

    Report Number
    1917413-2018-02499
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    February 26, 2015
    Report Date
    April 30, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    GIM
    UDI-DI
    50382903678636
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4191583. MEDICAL DEVICE EXPIRATION DATE: 12/31/2015. DEVICE MANUFACTURE DATE: 07/10/2014. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES HAD HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348541 BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. 4134589 50382903678636

    Patients

    Seq Age Sex Outcome Treatment
    1 Other