BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 2140355 · Received June 17, 2011

    Report

    Report Number
    2183502-2011-00489
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS LEAKING BELOW THE FLANGE IN THE PILOT PORT AFTER 4 DAYS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK