BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBE

    MDR report key: 3063085 · Received February 19, 2013

    Report

    Report Number
    2183502-2013-00025
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    December 14, 2012
    Report Date
    February 12, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE SUSTAINED DAMAGE AT THE CUFF. REPLACEMENT WAS REQUIRED DUR TO LEAKING AFTER 24 HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72794 BIVONA TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 1741712

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK