BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE

    MDR report key: 3820746 · Received May 1, 2014

    Report

    Report Number
    2183502-2014-00263
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SMITHS MEDICAL INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ALLEGING THAT THE TRACHEOSTOMY TUBE CUFF WAS FOUND TO BE LEAKING INTO THE TUBE LUMEN AFTER ONE DAY IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262501 BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INC. NA CS012474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK