BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY TRACHEOSTOMY TUBE

    MDR report key: 24524 · Received August 16, 1995

    Report

    Report Number
    MW1006723
    Event Type
    Injury
    Date Received
    August 16, 1995
    Date of Event
    July 20, 1995
    Report Date
    August 11, 1995
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CODED. TRACHEOSTOMY WAS PLUGGED PRIOR TO CODE. AIR LEAK NOTED, THE INNER CANNULA WAS PULLED AND REPLACED RESULTING IN AN IMMEDIATE IMPROVEMENT IN VENTILATION. IT WAS DISCOVERED THAT THE MFR HAS MADE CHANGES TO THEIR LINE OF TRACHEOSTOMY TUBES. THE PRODUCT ORDER IS THE SAME. THE PACKAGING OF THE ITEM IS THE SAME AS THE OLD, WITH THE EXEPTION OF A LABEL WHICH STATES "NEW AND IMPROVED". THE CHANGE IS CONFINED TO THE FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. ADDITIONALLY, THE WARNINGS IN THE PACKAGE INSERT HAVE ALSO CHANGED. THE FACILITY WAS NOT AWARE OF THE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL TPI, INC. 30 FR

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R