BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 51970 · Received May 23, 1996

    Report

    Report Number
    51970
    Event Type
    Malfunction
    Date Received
    May 23, 1996
    Date of Event
    May 11, 1996
    Report Date
    May 23, 1996
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT'S TRANCHEOSTOMY TUBE CUFF WOULD NOT HOLD PRESSURE. CUFF HAD BEEN FILLED WITH APPROX 8CC STERILE H2O. TRACH TUBE WAS PULLED AND REPLACED A SMALL HOLE WAS FOUND AT THE UNION OF CUFF AND LINE COMING FROM PILOT BALLOON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR