BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2100475 · Received May 17, 2011

    Report

    Report Number
    2936999-2011-00331
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 19, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 137-80 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 K841872. 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 COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TOP OF THE FLANGE WAS SLIPPING AND COULD NOT BE TIGHTENED DURING PT USE. AS A RESULT, THE PT WAS EXTUBATED AND REINTUBATED WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2011014825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention