BEUDAMED
    FDA Adverse Event Summary report: N

    BIVONA TRACHEOSTOMY TUBE

    MDR report key: 51028 · Received May 23, 1996

    Report

    Report Number
    51028
    Date Received
    May 23, 1996
    Date of Event
    May 9, 1996
    Report Date
    May 23, 1996
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    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 6CC STERILE H2O. TRACH TUBE WAS PULLED AND REPLACED. SMALL PIN HOLE WAS FOUND AT THE UNION OF THE CUFF AND THE LINE COMING FROM PILOT BALLOON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR