BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB-XII DUAL ENDED

    MDR report key: 512962 · Received February 16, 2004

    Report

    Report Number
    MW1031193
    Event Type
    Malfunction
    Date Received
    February 16, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 16, 2004
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BRUSH AT THE END OF A DISPOSABLE ENDOSCOPIC CLEANING BRUSH BROKE OFF DURING THE CLEANING OF AN ENDOSCOPE AND COULD NOT BE FOUND. THE ENDOSCOPE WAS RETURNED TO THE MANUFACTURER WHO STATE THEY EXAMINED THE SCOPE AND THE BRUSH WAS NOT IN THE SCOPE. THEY RETURNED THE SCOPE TO HOSP FOR USE. SCOPE WAS USED ON 9 PTS (STERILIZED WITH STERIS PRIOR TO EACH USE). THE LAST CLEANING PUSHED OUT THE MISSING COMPONENT BRUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CB-XII DUAL ENDED ENDOSCOPIC DISPOSABLE CLEANING BRUSH MNL BALLARD MEDICAL PRODUCTS 60218 233649

    Patients

    Seq Age Sex Outcome Treatment
    1 *