BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) TUBES

    MDR report key: 7477612 · Received May 1, 2018

    Report

    Report Number
    1917413-2018-01027
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    April 17, 2017
    Report Date
    May 31, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903667036
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED ENTRY OF 510(K)# TO EXEMPT.

    Additional Manufacturer Narrative · 1

    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. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® NO ADDITIVE (Z) TUBES WERE DRAWING LOW DUE TO NOT HAVING PROPER SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318384 BD VACUTAINER® NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER JKA BECTON, DICKINSON & CO. 6279828 50382903667036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other