BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 2913930 · Received December 7, 2012

    Report

    Report Number
    2183502-2012-00578
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THE TRACHEOSTOMY TUBE WAS LEAKING AT THE CUFF WHEN 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 CUFFED PEDIATRIC TRACHEOSTOMY TUBE JOH-TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CL109496

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK