BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2051022 · Received April 4, 2011

    Report

    Report Number
    2936999-2011-00249
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER# 313-50 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 K965132. THE SAMPLE IS ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG 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

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE IS LEAKING DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO EVAC TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2008077822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention