BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA FOME-CUF TRACHEOSTOMY TUBE

    MDR report key: 299674 · Received October 9, 2000

    Report

    Report Number
    1824231-2000-00003
    Event Type
    Malfunction
    Date Received
    October 9, 2000
    Date of Event
    August 10, 2000
    Report Date
    October 5, 2000
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE FUNCTIONED DURING INSERTION INTO PT, BUT MALFUNCTIONED ON ATTEMPTED REMOVAL. MALFUNCTION REOCCURRED ON INITIAL TEST, BUT FUNCTIONED NORMALLY ON REPEATED RETEST. NO ANOMALIES WERE FOUND DURING SUBSEQUENT DISASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA FOME-CUF TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES NA 841400

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention