BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINALYSIS URINE TUBE

    MDR report key: 7503367 · Received May 10, 2018

    Report

    Report Number
    1917413-2018-02450
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    January 14, 2016
    Report Date
    June 6, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    UDI-DI
    50382903649797
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO KDT. PMA / 510(K)# IS CORRECTED TO EXEMPT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® URINALYSIS URINE TUBE RUBBER STOPPERS WERE INTERFERING WITH THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346846 BD VACUTAINER® URINALYSIS URINE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. UNKNOWN 50382903649797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other