BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 1760399 · Received July 12, 2010

    Report

    Report Number
    2183502-2010-00281
    Event Type
    Injury
    Date Received
    July 12, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K914088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT ALLEGES THAT THE TRACHEOSTOMY TUBE INADVERTENTLY BECAME EXTUBATED WHICH REQUIRED MEDICAL INTERVENTION TO RE-ESTABLISH THE AIRWAY. THE REPORT STATES THAT THE PT "WAS MOVING AROUND" WHICH RESULTED IN THE PT SPONTANEOUSLY DECANNULATING. THE TRACH WAS REPLACED AND THE PT RECOVERED WITH NO INCIDENT RELATED MEDICAL SEQUELAE.

    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 1304544

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R