BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 1898306 · Received October 26, 2010

    Report

    Report Number
    2936999-2010-01286
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 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

    PART NUMBER: 317-80 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER THESE ARE A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K791045. THE SAMPLE 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 CALLER REPORTED THAT WATER DROPS WERE FOUND IN THE CUFF DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE THE PATIENT WITH A NEW TUBE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEL TUBE WITH LANZ BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2010059776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention