BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® TTS¿ 8.0MM TRACHEOSTOMY TUBE

    MDR report key: 6567157 · Received May 15, 2017

    Report

    Report Number
    3012307300-2017-01028
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 18, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 3230578, 3208597. ADDITIONAL 510(K): K083641. THE DEVICE IS CURRENTLY BEING EVALUATED; SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. DEVICE EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND A LARGE CUT/TEAR ON THE CUFF OF THE TRACHEOSTOMY TUBE. USING MAGNIFICATION, WEAR MARKS/ABRASIONS WERE OBSERVED AT THE CENTER OF THE CUT/TEAR ON THE CUFF. ALL CUFFED TRACHEOSTOMY TUBES ARE 100 PERCENT LEAK TESTED PRIOR TO RELEASE FOR DISTRIBUTION FROM THE MANUFACTURING SITE. WHILE NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF OF A BIVONA® TTS¿ 8.0MM TRACHEOSTOMY TUBE BROKE AND LEAKED AFTER SEVEN DAYS IN USE. CUFF PATENCY WAS TESTED PRIOR TO USE, AND THE CUFF WAS FILLED WITH STERILE WATER. A HOSPITAL PERSONNEL NOTICED THE FAULT WHEN THE VENTILATOR ALARM WENT OFF. THE PATIENT EXPERIENCED BREATHING DIFFICULTIES. THE TRACHEOSTOMY TUBE WAS REPLACED. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348353 BIVONA® TTS¿ 8.0MM TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1