BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONNA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE

    MDR report key: 3760865 · Received April 9, 2014

    Report

    Report Number
    2183502-2014-00195
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SMITHS MEDICAL INC
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. HEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ALLEGING THAT UPON PLACEMENT OF THE TRACHEOSTOMY TUBE, THE CUFF WAS FOUND TO BE LEAKING. THE PATIENT WAS IMMEDIATELY SUCTIONED AND AN EMERGENT EXCHANGE OF THE TRACHEOSTOMY TUBE WAS PERFORMED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212915 BIVONNA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE JOH - TRACHEOSTOMY TUBE JOH SMITHS MEDICAL INC NA CS009575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other