BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2065270 · Received April 12, 2011

    Report

    Report Number
    2936999-2011-00284
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEA
    Product Code
    BTR
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 317-85 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR U.S. DISTRIBUTED PART IS K965132. 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

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED AFTER ONE HOUR OF PT USE, THE CUFF COULD NOT BE INFLATED. IT WAS SUSPECTED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED BUT THE CALLER COULD NOT CONFIRM THE INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention