BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGHT TO THE SHAFT TRACH TUBE

    MDR report key: 384139 · Received March 2, 2002

    Report

    Report Number
    384139
    Event Type
    Injury
    Date Received
    March 2, 2002
    Date of Event
    February 4, 2002
    Report Date
    February 18, 2002
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT UNABLE TO BE VENTILATED WITH VENTILATOR - HAD TO BAG PT WITH 100% O2 TO KEEP SATS GREATER THAN 90%, CHANGED TRACHE TO BIRONA. PT PLACED BACK ON VENTILATOR DID FINE FOR APPROX 1 HOUR. THE STAFF HAD TO BAG PT WITH 100% TO KEEP SATS GREATER THAN 90%. CHANGED TRACHE AGAIN WITH 2ND BIRONA. PT VENTILATED WITH VENT UNTIL TRANSFER TO HOST HOSPITAL MICU. HOST HOSPITAL SWITCHED OUT THIS TRACHE TUBE TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGHT TO THE SHAFT TRACH TUBE TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES 670195 1059840

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening NOT USED FURTHER. 2002