BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7519905 · Received May 16, 2018

    Report

    Report Number
    1917413-2018-02412
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    June 9, 2017
    Report Date
    May 2, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678445
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. ADDITIONAL LOT NUMBER #: 7033587, ADDITIONAL EXPIRATION DATE: 06/30/2018, ADDITIONAL MANUFACTURE DATE: 02/02/2017. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THAT THERE WERE PLATELET CLUMPING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360206 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7033585 50382903678445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other