BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA MEDICAL TECHNOLOGIES

    MDR report key: 52068 · Received June 7, 1996

    Report

    Report Number
    52068
    Event Type
    Malfunction
    Date Received
    June 7, 1996
    Date of Event
    May 6, 1996
    Report Date
    May 23, 1996
    Manufacturer
    TRACHEOSTOMY TUBE
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT'S TRACHEOSTOMY TUBE CUFF WOULD NOT HOLD PRESSURE. CUFF HAD BEEN FILLED WITH APPROX 12CC STERILE WATER. TRACH TUBE WAS PULLED AND REPLACED. A SMALL PIN HOLE WAS FOUND AT THE UNION BETWEEN THE CUFF AND THE LINE COMING FROM THE PILOT BALLOON. 4 HRS LATER THE SAME PROBLEM OCCURRED AND THE TRACH TUBE WAS CHANGED AND A PINHOLE WAS FOUND IN IT ALSO. TWENTY-SIX HRS LATER THE SAME PROBLEM OCCURRED AND THE TUBE WAS CHANGED WITH THE SAME TYPE OF PINHOLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR