BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS TRACHEOSTOMY TUBE

    MDR report key: 1952070 · Received January 3, 2011

    Report

    Report Number
    2183502-2010-00644
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 24, 2009
    Report Date
    December 30, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. 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 EVALUATION.

    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. AN EMERGENT REPLACEMENT WAS REQUIRED. NO FURTHER INCIDENT RELATED MEDICAL SQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 1619007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other