BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA

    MDR report key: 572813 · Received February 11, 2005

    Report

    Report Number
    1824231-2005-00002
    Event Type
    Other
    Date Received
    February 11, 2005
    Date of Event
    January 8, 2005
    Report Date
    February 11, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE THIRD TUBE FAILED. IT HAD A TEAR 3/4 OF THE WAY AROUND THE TUBE. PT WAS TRANSPORTED TO THE HOSP DUE TO RESPIRATORY DISTRESS. NOW THEY ARE IN PICU BEING MONITORED. THIS WAS THE THIRD CUFF FAILURE FOR THIS PT IN SEVEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS TRACHEOSTOMY TUBE BTO SMITHS MEDICAL ASD, INC. * 1270220

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization