BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

    MDR report key: 1253118 · Received September 26, 2008

    Report

    Report Number
    9610530-2008-00045
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR INFORMED US OF AN EVENT THAT THE CUFF WAS ALLEGEDLY PUNCTURED. IT IS NOT KNOWN IF THE UNIT WAS PRETESTED PER THE INSTRUCTIONS FOR USE. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) 73 BTR - TUBE, TRACHEAL WITH/WITHOUT CONNECTOR BTR SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * 901257

    Patients

    Seq Age Sex Outcome Treatment
    1 *