BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX DIC TRACHEOSTOMY TUBE

    MDR report key: 2192612 · Received August 1, 2011

    Report

    Report Number
    MW5021592
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 8.0 MM PORTEX TRACHEOSTOMY TUBE WAS TESTED PRIOR TO USE. CUFF WOULD FILL WITH AIR, BUT AFTER INSERTION INTO THE PT, IT WOULD NOT HOLD AIR AND IT WAS REMOVED. A SECOND 8.0 MM PORTEX TRACHEOSTOMY TUBE WAS INSERTED AND THE CUFF MAINTAINED THE AIR PRESSURE. THE PT TOLERATED THE PROCEDURE WELL. EXPIRATION DATE: 10/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX DIC TRACHEOSTOMY TUBE 8.0 MM TRACHEOSTOMY TUBE JOH SMITHS MEDICAL 503080 1939286

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other