BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5940516 · Received September 9, 2016

    Report

    Report Number
    2183502-2016-01945
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 9, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K913859 AND K083641. THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE USED 7.0MM TTS¿ ADULT TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH 2 ADDITIONAL TRACHEOSTOMY TUBES. DURING FUNCTIONAL TESTING, 14CC'S OF AIR WAS INSERTED INTO THE DEVICE AND A SMALL LEAK WAS DETECTED IN THE CUFF. USING MAGNIFICATION THE CUT WAS EXAMINED AND A TINY ABRADED AREA WAS OBSERVED. NO EVIDENCE WAS FOUND OF THE CUFF DETACHING FROM THE SHAFT. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUT ON THE CUFF; HOWEVER, NO EVIDENCE WAS FOUND TO INDICATE A MANUFACTURING DEFECT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE HAD ITS BALLOON FAIL DURING USE. THE REPORTER CLARIFIED THAT THE CUFF WAS DEFLATED AND LEAKED, WHICH OCCURRED WHILE THE PATIENT WAS SITTING IN THEIR POWER WHEELCHAIR DOING NO ACTIVITY. THIS EVENT OCCURRED WITHIN A WEEK AFTER PLACEMENT. THE CUFF WAS OBSERVED TO HAVE MANY PINHOLES AND LEAKS. A CUFF PATENCY CHECK WAS OBSERVED BY A RESPIRATORY THERAPIST AND IT WAS CONFIRMED THAT IT FUNCTIONED WITH NO LEAKS. THE HUSBAND OF THE PATIENT HEARD AUDIBLE SOUNDS FROM THE PATIENT "AS IF AIR WAS LEAKING FROM AROUND THE CUFF," AND HE STATED THAT AUDIBLE COUGHING WAS ONLY HEARD WHEN CUFF RUPTURED AND WATER LEAKED OUT. THE HUSBAND OBSERVED MULTIPLE LEAKS UPON TAKING OUT THE TRACHEOSTOMY TUBE; HE STATED THERE WERE NO PINHOLES ON THE CUFF, WATER LEAKED FROM THE TOP OF THE CUFF, AND THE "SEAM" WHERE THE CUFF MEETS THE SHAFT DETACHED AS IF THERE WAS NOT ENOUGH ADHESIVE TO SEAL AND HOLD THE CUFF DOWN. WHEN THE HUSBAND INJECTED WATER INTO THE PILOT BALLOON, WATER SHOT OUT OF THE CUFF AND UP THROUGH THE TRACHEOSTOMY TUBE. THE HUSBAND NOTED HE DOES NOT CHECK CUFF PATENCY PRIOR TO INSERTION. TRACHEOSTOMY TUBE WAS PLACED BY HUSBAND BY TAKING THE TUBE OUT OF THE STERILE CONTAINER, LUBRICATING THE TUBE AND CUFF WITH KY JELLY, AND INTUBATING THE TUBE. THESE STEPS WERE DONE SINCE (B)(6) 2016. AN EMERGENT TRACHEOSTOMY CHANGE WAS REQUIRED AS THE CUFF WOULD NOT HOLD WATER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592664 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC. 3136486

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention