BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 7.5MM CUFFED TRACHEAL TUBES

    MDR report key: 2161744 · Received May 13, 2011

    Report

    Report Number
    2183502-2011-00416
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.,
    Product Code
    JOH
    PMA / PMN Number
    PREAMENDMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD AND RELATED DOCUMENTS DID NOT SHOW ANY RELATED MANUFACTURING ISSUES. INSPECTION AND TESTING INDICATED THAT THE DEVICE MET WITH REQUIREMENTS PRIOR TO RELEASE. THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. INVESTIGATION DETERMINED THAT THE RETURNED SAMPLE MET MANUFACTURING AND DIMENSIONAL REQUIREMENTS FOR THIS PRODUCT. THE DEVICE PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNK AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX 7.5MM CUFFED TRACHEAL TUBES ENDOTRACHEAL TUBES JOH SMITHS MEDICAL INTERNATIONAL LTD., NA 1848552

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK