BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 7506858 · Received May 11, 2018

    Report

    Report Number
    1917413-2018-02531
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    May 25, 2017
    Report Date
    April 30, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903686600
    PMA / PMN Number
    K971449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7033742. MEDICAL DEVICE EXPIRATION DATE: 07/31/2018. 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® SERUM BLOOD COLLECTION TUBES HAD INCORRECT COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348311 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6343859 50382903686600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other