BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6670648 · Received June 27, 2017

    Report

    Report Number
    3012307300-2017-01365
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 7, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006056
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT'S BIRTH YEAR WAS (B)(6). THE EXACT DATE OF BIRTH IS UNKNOWN. POTENTIAL LOT NUMBERS - 3233452 AND 3233453 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

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ONE USED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION USING MAGNIFICATION REVEALED AN AREA WITH AN ABRASION ON THE TRACHEOSTOMY TUBE. FUNCTIONAL TESTING WAS PERFORMED TO TEST FOR LEAKAGE USING AIR TO FILL THE CUFF. LEAKAGE WAS IMMEDIATELY DETECTED UPON FILLING THE CUFF. THE COMPLAINANT STATED THAT THE DEVICE PASSED TESTING PRIOR TO USE, AND THE DEVICE WAS IN USE FOR APPROXIMATELY ONE DAY PRIOR TO THE DETECTION OF THE LEAK. 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® ADULT TTS¿ TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING AFTER ONE DAY IN USE. THE FAULT WAS NOTICED BY A PHYSICIAN, AFTER THE VENTILATOR ALARMED. THE PHYSICIAN THEN REMOVED THE TRACHEOSTOMY TUBE AND TESTED IT WITH WATER, AND NOTICED THE CUFF LEAKED. THE CUFF WAS FILLED WITH STERILE WATER, AND CUFF PATENCY WAS TESTED PRIOR TO USE. STERILE WATER WAS USED TO FILL THE CUFF. THE TRACHEOSTOMY TUBE WAS REPLACED. THE EVENT WAS REPORTED AS BEING RESOLVED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449757 BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006056

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR FOLEY| NG