BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6651735 · Received June 19, 2017

    Report

    Report Number
    3012307300-2017-01343
    Event Type
    Death
    Date Received
    June 19, 2017
    Date of Event
    June 5, 2017
    Report Date
    September 1, 2017
    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 Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MFR: 3012307300-2017-02002, 3012307300-2017-01129, 3012307300-2017-01130, 3012307300-2017-01131, 3012307300-2017-01374, 3012307300-2017-01375, 3012307300-2017-01376, 3012307300-2017-01377, AND 3012307300-2017-01378 (SAME PATIENT).

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) - 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 ADDITIONALLY REPORTED THAT THE PATIENT PASSED AWAY UNEXPECTEDLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "PINHOLE" WAS FOUND IN THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE DURING USE. THE CUFF WAS TESTED WITH AIR AND WATER PRIOR TO USE, AND "WORKED FINE". THE PATIENT'S AIRWAY WAS CHECKED FOR ANY OBSTRUCTION, BUT NOTHING WAS FOUND. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432463 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006056

    Patients

    Seq Age Sex Outcome Treatment
    1 Death