BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TRACHEOSTOMY TUBE

    MDR report key: 34847 · Received July 24, 1996

    Report

    Report Number
    34847
    Event Type
    Malfunction
    Date Received
    July 24, 1996
    Date of Event
    May 11, 1996
    Report Date
    July 22, 1996
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAS A TRACHEOSTOMY AND IS VENTILATOR DEPENDENT. ON 5/11/96 THE PT NEEDED SUCTIONING AND THE RN WAS UNABLE TO DETACH THE VENTILATION ADAPTER FROM THE TRACH TUBE. THE PLASTIC SWIVEL SLEEVE OF THE TRACH WAS ANCHORED INTO THE VENTILATOR AND IT WAS IMPOSSIBLE TO DISENGAGE THE TWO. THIS NECESSITATED AN EMERGENCY TRACH CHANGE ON THE PT. THERE WAS NO CHANGE IN STATUS OF THE PT. WHEN THE TRACH DID COME APART, THE SWIVEL SLEEVE REMAINED STUCK IN THE VENT AND COULD ONLY BE REMOVED BY PRYING IT OUT WITH HEMOSTATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO