BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX D.I.C. TRACHEOSTOMY TUBE

    MDR report key: 2033262 · Received March 24, 2011

    Report

    Report Number
    MW5019954
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 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

    AFTER INSERTION, THE CUFF ON THE 8.0MM PORTEX TRACHEOSTOMY TUBE WAS NOTED TO BE LEAKING AND SUBSEQUENTLY CHANGED. NO ILL EFFECTS TO PATIENT. PATIENT TOLERATED THE PROCEDURE WELL. EXP DATE: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX D.I.C. TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE 8.0MM JOH SMITHS MEDICAL ASD, INC. 1842473

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other