BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS TRACHESTOMY TUBE

    MDR report key: 2241547 · Received August 11, 2011

    Report

    Report Number
    2183502-2011-00576
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 10, 2011
    Manufacturer
    SMITHS MEDICAL ASD INC
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    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 AFTER AN UNK AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS TRACHESTOMY TUBE JOH - TRACHEOTOMY TUBE JOH SMITHS MEDICAL ASD INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK