BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2160945 · Received June 16, 2011

    Report

    Report Number
    2936999-2011-00426
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER 125-41 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K771219. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES THE TUBES THAT CAME OUT OF THE PT'S MOUTH ARE MARKED INCORRECTLY, THE BLUE SHOULD SAY "BRONCHIAL" AND IT DOESN'T IT SAYS "TRACHEAL" AND THE CLEAR TUBE SAYS "BRONCHIAL" WHICH SHOULD SAY "TRACHEAL". THE CALLER REPORTED THIS WAS DISCOVERED WHEN THE TUBE WAS BEING REMOVED FROM THE PT SO NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT BRONCHO-CATH ENDOBRONCHIAL TUBE CBI COVIDIEN, FORMERLY TYCO HEALTHCARE 2010027179

    Patients

    Seq Age Sex Outcome Treatment
    1