BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOBBS MEDICAL MICROBIOLOGY BRUSH

    MDR report key: 17617995 · Received August 24, 2023

    Report

    Report Number
    1220592-2023-00004
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 24, 2023
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FDX
    UDI-DI
    M84943100
    PMA / PMN Number
    K893729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER, A MICROBIOLOGY BRUSH WAS USED ON A PATIENT FOR BRONCHOSCOPY. WHILE TAKING THE BRUSH SAMPLE, THE BLUE PLASTIC TEAR DROP TIP ON THE DISTAL END OF THE BRUSH CAME OFF AND FELL INTO THE PATIENT'S BRONCHUS. THE PLASTIC TIP WAS REMOVED WITH SUCTION, AND NO MAJOR DAMAGE WAS VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123196 HOBBS MEDICAL MICROBIOLOGY BRUSH MICROBIOLOGY BRUSH FDX HOBBS MEDICAL, INC. 4310 H10-22-072 M84943100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown