BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7082802 · Received December 5, 2017

    Report

    Report Number
    1917413-2017-00320
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    December 2, 2015
    Report Date
    November 7, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JTW
    PMA / PMN Number
    K790366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: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. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PLASTIC URINE COLLECTION CUP HAD URINE LEAKAGE FROM LID OF THE CUP. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862175 BD VACUTAINER® PLASTIC URINE COLLECTION CUP COLLECTION CUP JTW BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other