BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 44411 · Received September 24, 1996

    Report

    Report Number
    1824231-1996-00011
    Event Type
    Malfunction
    Date Received
    September 24, 1996
    Date of Event
    August 16, 1996
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN CRIB AND ON VENTILATOR. PT HEARD TO MAKE CRYING SOUNDS AND VENTILATOR ALARM SOUNDED. ON INVESTIGATION, TUBE SHAFT WAS OBSERVED STILL IN PT, BUT PROXIMAL EXTENSION TUBE WAS BROKEN AND CONNECTED TO REST OF SHAFT BY UNCOILED WIRE REINFORCING. TUBE WAS IMMEDIATELY REPLACED AND PT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA FLEXTEND TRACHEOSTOMY TUBE CUFFLESS PEDIATRIC TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES NA 596870

    Patients

    Seq Age Sex Outcome Treatment
    1 28 MO Required Intervention