BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5953795 · Received September 15, 2016

    Report

    Report Number
    2183502-2016-02004
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 14, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): K913859 AND K083641. SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 15MM CONNECTOR OF A BIVONA ADULT TTS TRACHEOSTOMY TUBE WAS TOO LARGE, WHICH MADE THE TUBE "TOO TIGHT TO PULL OUT" WHEN CONNECTED TO A SWIVEL CONNECTOR. THE EVENT OCCURRED WHILE PATIENT WAS IN HOMECARE NURSING AND WAS OBSERVED BY A FAMILY MEMBER WHILE THE TUBE WAS BEING DISCONNECTED FROM VENTILATOR FOR CLEANING. THE CUFF WAS FILLED WITH STERILE WATER AND CUFF PATENCY WAS TESTED PRIOR TO USE. AN EMERGENT TRACHEOSTOMY TUBE CHANGE WAS REQUIRED DUE TO THE INCIDENT. THE INCIDENT WAS CONSIDERED RESOLVED. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606046 BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention