BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIVONA

    MDR report key: 592140 · Received April 7, 2005

    Report

    Report Number
    1824231-2005-00006
    Event Type
    Other
    Date Received
    April 7, 2005
    Report Date
    April 7, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS TUBE IS FALLING APART. LOOKS LIKE THE 'GLUE' ISN'T HOLDING THE CANULA TO THE NECK FLANGE. A PREVIOUS INCIDENT WAS ALSO REPORTED STATING THE INNER CANULA FELL DOWN INTO PT'S TRACHEA AND HAD TO BE REMOVED FROM THEIR TRACHIA IN THE OR. NO OTHER INFORMATION OR PRODUCT WAS PROVIDED FOR THE PREVIOUS INCIDENT TO ENABLE A DETERMINATION TO BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOMIZED TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. * CL33104

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Other