BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ URINE CUP

    MDR report key: 6967056 · Received October 20, 2017

    Report

    Report Number
    2243072-2017-00181
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    December 10, 2015
    Report Date
    October 5, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    JTW
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD¿ URINE CUP LEAKED WHEN BEING TRANSFERRED THROUGH A TUBE SYSTEM. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743628 UNSPECIFIED BD¿ URINE CUP URINE COLLECTION SYSTEM JTW BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other