BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY CARE TRAY

    MDR report key: 190433 · Received October 2, 1998

    Report

    Report Number
    9612030-1998-00007
    Event Type
    Malfunction
    Date Received
    October 2, 1998
    Manufacturer
    KENDALL
    Product Code
    LRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO RPTR, PT WAS USING THE TRACH BRUSH TO CLEAN HIS TRACH. WHILE HE WAS DOING SO, THE BRUSH PORTION OF THE BRUSH BROKE OFF AND MIGRATED DOWN PT'S THROAT AND LODGED IN HIS RIGHT LUNG. LATER THAT SAME DAY, HE HAD TO HAVE THE BRUSH REMOVED. AS THE BRUSH TRAVELED DOWN HIS THROAT, THE FRAGMENT TORE A PORTION OF HIS THROAT. A BALLOON DEVICE WAS PLACED IN PT'S THROAT TO PROTRECT AND COVER THE TORN PORTION OF HIS TRACHEA. ATTY FOR THIS PT STATED, "WHILE THE FRONT PACKAGE OF YOUR TRACHEOSTOMY CARE TRAY STATES THAT THE INNER CANNULA SHOULD BE REMOVED PRIOR TO CLEANING, WE BELIEVE THAT IT IS CERTAINLY FORESEEABLE FOR SOMEONE TO ATTEMPT TO CLEAR THE INNER CANNULA WITHOUT REMOVING THE INNER CANNULA AND GOING THROUGH ALL OF THE PROCEDURAL STEPS FOR CLEANING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHEOSTOMY CARE TRAY TRACH CARE TRAY LRQ KENDALL * CD0401KG

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other