BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D.I.C. TRACHEOSTOMY TUBE

    MDR report key: 101056 · Received June 27, 1997

    Report

    Report Number
    1217052-1997-00029
    Event Type
    Injury
    Date Received
    June 27, 1997
    Report Date
    May 29, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL ALLEGES THAT THE OBESE PT'S TRACHEOSTOMY TUBE, WHICH HAD ONLY BEEN IN PLACE FOR A SHORT TIME FOLLOWING SURGERY, SPONTANEOUSLY EXTUBATED RESULTING IN A CODE SITUATION. THE PT WAS SUCCESSFULLY RESUSCITATED AND REINTUBATED WITH ANOTHER MFR'S ADJUSTABLE LENGTH TRACHEOSTOMY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D.I.C. TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE AND TUBE CUFF BTO SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening