BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1961053 · Received January 11, 2011

    Report

    Report Number
    2936999-2011-00017
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 PILOT BALLOON DEVELOPED A LEAK DURING PATIENT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. THE CALLER REPORTED THAT VISUAL INSPECTION OF THE TUBE REVEALED A HOLE IN THE PILOT BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LO-CONTOUR MURPHY TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2010028156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention