BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6673481 · Received June 28, 2017

    Report

    Report Number
    3012307300-2017-01376
    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, 3012307300-2017-01374, 3012307300-2017-01375, 3012307300-2017-01377, AND 3012307300-2017-01378 (SAME PATIENT).

    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, CAUSING A LEAK. THE PATIENT'S AIRWAY WAS CHECKED FOR ANY OBSTRUCTION BUT NOTHING WAS FOUND. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01374, 3012307300-2017-01375, 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
    454100 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