BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5915328 · Received August 30, 2016

    Report

    Report Number
    2183502-2016-01827
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K913859 & K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. 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

    IT WAS REPORTED THAT A BIVONA ADULT TTS TRACHEOSTOMY TUBE HAD A CUFF FAILURE EXACTLY ONE WEEK AFTER INITIAL USE. THE CUSTOMER NOTED FILLING CUFF WITH WATER CAUSED WATER TO SQUIRT OUT OF A PIN-LIKE HOLE. THIS EVENT OCCURRED WHILE THE CUSTOMER WAS ASLEEP AT AROUND 5AM, AND WAS OBSERVED BY CUSTOMER'S MOTHER. AN EMERGENCY TRACHEOSTOMY CHANGE WAS CONDUCTED TO RESOLVE THE REPORTED ISSUE. XANAX, OXYGEN, AND OXYCODONE WERE TAKEN FOR CALMING DOWN, LOW OXYGEN, AND SORE STOMA, RESPECTIVELY. NO PERMANENT INJURY WAS REPORTED. CUFF PATENCY WAS TESTED PRIOR TO USE WITH STERILE WATER. STERILE WATER WAS USED TO FILL THE CUFF FOR USE. TRACHEOSTOMY TUBE IS CHANGED MONTHLY WITH A NEW UNOPENED ONE. SEE MFR: 2183502-2016-01828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566843 BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC. 3048307

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention