BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 60225 · Received October 10, 1996

    Report

    Report Number
    2029387-1996-00134
    Event Type
    Malfunction
    Date Received
    October 10, 1996
    Date of Event
    September 10, 1996
    Report Date
    October 8, 1996
    Manufacturer
    MALLINCKRODT MEDICAL, INC
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHILE THE HOSP STAFF WAS PROVIDING ROUTINE CARE OF THE PT'S TRACHEOSTOMY TUBE, IT WAS DISCOVERED THAT THE DISPOSABLE INNER CANNULA (DIC) WAS PROTRUDING. IT WAS REPORTED THAT THE INNER CANNULA HAD BROKEN AND COMPLETELY SEPARATED; THE TUBE HAD MIGRATED UPWARD, POSSIBLY DUE TO THE PT COUGHING. THE TRACH TUBE HAD BEEN PLACED 8/20/96 (CHANGED MONTHLY). THE DICS ARE CHANGED EVERY 12 HOURS. THE PT WAS BEING WEANED OFF THE VENTILATOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC 8DIC M62895000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN