BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOBRONCHIAL TUBE

    MDR report key: 97363 · Received June 11, 1997

    Report

    Report Number
    MW1011454
    Event Type
    Other
    Date Received
    June 11, 1997
    Date of Event
    May 16, 1997
    Report Date
    May 29, 1997
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    CBI
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, SUDDEN LARGE LEAK IN CIRCLE SYSTEM DETECTED. TRACHEAL CUFF WOULDN'T HOLD PRESSURE. THROAT PACKED W/9 H2O SOAKED SPONGES. GOOD SATS THROUGHOUT. PT VOMITED & POSSIBLY ASPIRATED. TUBE THROWN OUT BY ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOBRONCHIAL TUBE ENDOBRONCHIAL TUBE CBI MALLINCKRODT MEDICAL TPI, INC. * #1996-07-2906

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other