BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE CYTOLOGY BRUSH

    MDR report key: 24451 · Received August 14, 1995

    Report

    Report Number
    MW1006699
    Event Type
    Malfunction
    Date Received
    August 14, 1995
    Date of Event
    July 27, 1995
    Report Date
    July 27, 1995
    Manufacturer
    AMERICAN CATHETER, CORP.
    Product Code
    BTG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TAKING CYTOLOGY BRUSH BIOPSIES DURING FIBEROPTIC BRONCHOSCOPY, CYTOLOGY BRUSH (APPROX 6 INCHES IN LENGTH) BROKE OFF & REMAINED IN LUNG. REMOVED SUCCESSFULLY WITH FORCEPS WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CYTOLOGY BRUSH BRUSH BTG AMERICAN CATHETER, CORP. 7610 045903

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR