BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 7452427 · Received April 23, 2018

    Report

    Report Number
    1917413-2018-00880
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    October 10, 2016
    Report Date
    September 10, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORDS FOR BATCH 6090961 BEEN REVIEWED WITH NO ISSUES BEING IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES WERE DRAWING LOW.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX #: (B)(6). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LOW DRAW WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES WERE DRAWING LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292803 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6090961 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Other