BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX DIC CUFFED TRACHEOSTOMY TUBE

    MDR report key: 1932625 · Received December 14, 2010

    Report

    Report Number
    MW5018600
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OPERATING ROOM FOR TRACHEOSTOMY. UPON INSERTION OF A 0.8MM CUFFED PORTEX D.I.C. TRACHEOSTOMY TUBE, THE CUFF BROKE. NEW TRACHEOSTOMY WAS IMMEDIATELY OBTAINED AND IT WAS INSERTED WITHOUT INCIDENT. PER SURGEON'S OPERATIVE REPORT, THE TRACHEA WAS SIGNIFICANTLY CALCIFIED. NO HARM TO PT. EXPIRATION DATE: 07/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX DIC CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE 8.0MM JOH SMITHS MEDICAL ASD, INC. NA 1865022

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other