BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA MEDICAL TECHNOLOGIES

    MDR report key: 402956 · Received June 28, 2002

    Report

    Report Number
    1824231-2002-00006
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Date of Event
    May 23, 2002
    Report Date
    June 28, 2002
    Manufacturer
    BIVONA, INC.
    Product Code
    BTO
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOMECARE NURSE ON DUTY ATTENDED TO THE PATIENT WHEN THE VENTILATOR ALARMED AND NOTICED A TEAR IN THE TRACH ABOVE THE NECK FLANGE. THE HOMECARE NURSE REMOVED AND INSERTED ANOTHER TRACH WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA MEDICAL TECHNOLOGIES CUFFLESS 4.5 CUSTOMIZED FLEXTEND TRACH BTO BIVONA, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention