BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6595238 · Received May 26, 2017

    Report

    Report Number
    3012307300-2017-01131
    Event Type
    Death
    Date Received
    May 26, 2017
    Report Date
    January 2, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006056
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) NUMBER: 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.

    Additional Manufacturer Narrative · 1

    THREE DEVICES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE CUFF WAS CUT/TORN AT THE END OF THE DEVICE. IT WAS OBSERVED THAT THERE WERE TINY SCRATCHES NEXT TO THE RIPPED CUFFS. IT WAS SUSPECTED THAT THE DEVICES CAME INTO CONTACT WITH A SHARP OBJECT EXTERNALLY OR HARD CARTILAGE INTERNAL TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL SPECIFICATIONS WERE WITHIN MANUFACTURING SPECIFICATIONS. DIMENSIONAL ANALYSIS OF THE CUFFS MET THE WALL THICKNESS SPECIFICATION. BASED ON THE EVIDENCE, A ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SEE MFR: 3012307300-2017-02002, 3012307300-2017-01129, 3012307300-2017-01130, 3012307300-2017-01343, 3012307300-2017-01374, 3012307300-2017-01375, 3012307300-2017-01376, 3012307300-2017-01377, AND 3012307300-2017-01378 (SAME PATIENT).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE "RUPTURED". NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01129 AND 3012307300-2017-01130.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT PASSED AWAY UNEXPECTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374564 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3238414 15021312006056

    Patients

    Seq Age Sex Outcome Treatment
    1 Death