BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX D.I.C. TRACHEOSTOMY TUBE 8.0MM

    MDR report key: 2261329 · Received September 14, 2011

    Report

    Report Number
    MW5022285
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 14, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    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

    AS PORTEX D.T.C. TRACH TUBE WAS PASSED THROUGH THE PT'S TRACHEA, THE DOCTOR NOTED THAT THE CUFF WAS BROKEN UPON INFLATION. TRACH TUBE WAS REMOVED AND REPLACED WITH ANOTHER 8.0MM PROTEX D.I.C. TRACHEOTOMY TUBE OVER A SUCTION CATHETER. VENTILATION CONTINUED WITHOUT DIFFICULT. THE PT TOLERATED THE PROCEDURE WELL. ANOTHER TUBE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX D.I.C. TRACHEOSTOMY TUBE 8.0MM CUFFED TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. 2028670

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other