BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    MDR report key: 7575406 · Received June 6, 2018

    Report

    Report Number
    2243072-2018-01054
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    November 7, 2016
    Report Date
    May 11, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    KDW
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE MANUFACTURER: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. MANUFACTURING LOCATION: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4)HAS BEEN LISTED. 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 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE HAD "ERRONEOUS RESULTS" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417910 BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER KDW BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other