BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6673466 · Received June 28, 2017

    Report

    Report Number
    3012307300-2017-01374
    Event Type
    Death
    Date Received
    June 28, 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

    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.

    Additional Manufacturer Narrative · 1

    SEE MFR: 3012307300-2017-02002, 3012307300-2017-01129, 3012307300-2017-01130, 3012307300-2017-01131, 3012307300-2017-01343, 3012307300-2017-01375, 3012307300-2017-01376, 3012307300-2017-01377, AND 3012307300-2017-01378 (SAME PATIENT).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE LEAKED DURING USE. THE CUFF WAS TESTED WITH AIR AND WATER PRIOR TO USE AND IT WAS NOTED IT "WORKED FINE". THE PATIENT'S AIRWAY WAS CHECKED FOR OBSTRUCTION, BUT NOTHING WAS FOUND. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01375, 3012307300-2017-01376, 3012307300-2017-01377, AND 3012307300-2017-01378.

    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
    453909 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3338867 15021312006056

    Patients

    Seq Age Sex Outcome Treatment
    1 Death