BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 4230300 · Received October 21, 2014

    Report

    Report Number
    2183502-2014-00785
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 RECEIVED STATING THE TRACHEOSTOMY TUBE WAS FOUND LEAKING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667190 BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK