BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 3040588 · Received March 12, 2013

    Report

    Report Number
    2183502-2013-00090
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    March 11, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DEFLATING AT THE CUFF 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
    104365 BIVONA TTS FLEXTEND TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CL105481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK