BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TTS 4.0 MM UNCUFFED PEDIATRIC TRACHEOSTOMY

    MDR report key: 1781386 · Received July 30, 2010

    Report

    Report Number
    2183502-2010-00335
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Report Date
    July 28, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. 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 EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATES THAT AN HME VALVE COULD NOT BE REMOVED FROM THE 15MM CONNECTOR OF THE SITU TRACHEOSTOMY TUBE. THE TRACH WAS REMOVED AND REPLACED. THE PT RECOVERED WITH NO INCIDENT RELATED MEDICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS 4.0 MM UNCUFFED PEDIATRIC TRACHEOSTOMY JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK