BEUDAMED
    FDA Adverse Event Death Summary report: N

    (SHILEY) MALLINCKRODT MEDICAL, INC.

    MDR report key: 250105 · Received November 16, 1999

    Report

    Report Number
    250105
    Event Type
    Death
    Date Received
    November 16, 1999
    Date of Event
    September 28, 1999
    Report Date
    November 12, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST ATTEMPTED TO SUCTION PT AND WAS UNABLE TO GET THE SUCTION CATHETER THROUGH THE TRACH TUBE. CALLED FOR RT SUPERVISOR WHO ALSO ATTEMPTED AND WAS UNABLE TO PASS THE CATHETER THROUGH. SUPERVISOR DEFLATED CUFF, ATTEMPTED REPOSITIONING WITHOUT SUCCESS - PT PRESSURE WAS 70-80 AND WAS NOT GETTING SET TIDAL VOLUME. TUBE WAS REMOVED AND 8MM NEW TUBE INSERTED AND BAGGING PT WITH 100% O2. IN BETWEEN, THE PT WENT PULSELESS AND A CODE BLUE WAS INITIATED. MD'S RESPONDED AND REINTUBATION WAS ATTEMPTED. CODE BLUE PROTOCOL FOLLOWED, BUT UNSUCCESSFUL. PT PRONOUNCED DEAD BY HOUSE MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (SHILEY) MALLINCKRODT MEDICAL, INC. FLEXIBLE TRACH TUBE BTO MALLINCKRODT MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death SHILEY-FLEXIBLE TRACH TUBE (STOP'D).