BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1760764 · Received July 14, 2010

    Report

    Report Number
    2936999-2010-01030
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 14, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    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# 135-70 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, PN# 86550 IS OF ESSENTIALLY IDENTICAL DESIGN AND IS DISTRIBUTED IN THE U.S. 510K FOR US DISTRIBUTED PART IS K841872. THE CUSTOMER STATED THAT 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 THE END CLINICIAN EXPERIENCED DIFFICULTY DEFLATING THE CUFF DURING PATIENT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT REINFORCED TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 2009105935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention