BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 7488722 · Received May 4, 2018

    Report

    Report Number
    1917413-2018-02601
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    June 7, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7033864; MEDICAL DEVICE EXPIRATION DATE: 08/31/2017; DEVICE MANUFACTURE DATE: 02/02/2017. 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® 9NC 0.129M PLUS BLOOD COLLECTION TUBES "CITRATE - 363080 - FM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331359 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6342510 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other