BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOBBS MEDICAL MICROBIOLOGY BRUSH

    MDR report key: 20309145 · Received September 26, 2024

    Report

    Report Number
    1220592-2024-00005
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 24, 2024
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FDX
    UDI-DI
    M84943100
    PMA / PMN Number
    K893729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND WAS DISCARDED BY THE HEALTHCARE FACILITY. THE DEVICE IS INTENDED FOR USE IN THE GASTROINTESTINAL TRACT, NOT IN THE LUNGS. USE IN THE LUNGS IS THEREFORE CONSIDERED OFF-LABEL USE. MISBRANDED PRODUCTS WITHIN THIS PRODUCT FAMILY LABELED AS "BRONCHIAL" WERE RECALLED BY HOBBS MEDICAL IN 2021 (REF Z-0711-2022), AND AFFECTED CONSIGNEES NOTIFIED. CONFIRMED THAT THE DEVICE LOT INVOLVED IN THIS COMPLAINT WAS PROPERLY LABELED FOR GASTROINTESTINAL USE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION ON THE PATIENT'S CONDITION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL ATRAUMATIC BALL TIP OF THE MICROBIOLOGY BRUSH FELL OFF WHICH THE DEVICE WAS IN THE PATIENT'S RIGHT UPPER LOBE OF THE LUNG. ACCORDING TO THE PHYSICIAN, THEY NOTICED THE TIP HAD FALLEN OFF WHILE INSIDE THE LUNG AND WHEN THE DEVICE WAS RETRACTED FROM THE SCOPE, THERE WAS NO TIP ON THE DEVICE. PHYSICIAN CONFIRMED THE TIP WAS NOT LODGED IN THE SCOPE AND DID NOT FEEL IT WOULD BE POSSIBLE TO SUCTION THE SEPARATED COMPONENT OUT OF THE LUNG. PHYSICIAN PLANNED TO SEND THE PATIENT FOR SCANS TO IDENTIFY THE LOCATION OF THE TIP IN THE LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263332 HOBBS MEDICAL MICROBIOLOGY BRUSH MICROBIOLOGY BRUSH FDX HOBBS MEDICAL, INC. 4310 H01-24-338 M84943100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other