BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5961100 · Received September 19, 2016

    Report

    Report Number
    2183502-2016-02013
    Event Type
    Death
    Date Received
    September 19, 2016
    Report Date
    August 22, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510(K): K914088 AND K083641.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CHILD PATIENT EXPERIENCED A TRACHEAL HEMORRHAGE AND HAD EXPIRED WHILE USING A BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE. THE TRACHEOSTOMY TUBE IS WITH THE PATIENT IN THE MORGUE AS A POST-MORTEM PROCEDURE IS BEING CARRIED OUT. SMITHS MEDICAL HAS REQUESTED THE DEVICE AND INCIDENT DETAILS FROM THE FACILITY. ANY FURTHER DETAILS RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611919 PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L