BEUDAMED
    FDA Adverse Event Summary report: N

    SHILEY (314) 654-2000

    MDR report key: 404890 · Received July 11, 2002

    Report

    Report Number
    MW1025569
    Date Received
    July 11, 2002
    Date of Event
    May 30, 2002
    Report Date
    June 19, 2002
    Manufacturer
    MALLINCKRODT, INC. CRITICAL CARE DIV.
    Product Code
    BTO
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CRACK IN SHILEY TRACH PREVENTED AN ADEQUATE SEAL AND ALLOWED IT TO DISENGAGE FROM VENTILATOR CIRCUIT. THE CRACKED TRACH WAS REPLACED WITH A NEW #8 TRACH. NO KNOWN INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY (314) 654-2000 TRACH 1-888-744-1414 BTO MALLINCKRODT, INC. CRITICAL CARE DIV. 8 DCT *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR