BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1980172 · Received February 1, 2011

    Report

    Report Number
    2936999-2011-00080
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    September 1, 2010
    Report Date
    October 4, 2010
    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# (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 UNITED STATES DISTRIBUTED PART IS K082520. THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE CUSTOMER DID PROVIDE A LOT#. MANUFACTURING WILL PERFORM A LOT HISTORY REVIEW OF THE REPORTED LOT AS PART OF THE INVESTIGATION. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE LOT REVIEW, THEN A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE DEVELOPED A KINK DURING PATIENT USE. THE END CLINICIAN REPORTED THAT THE PATIENT EXPERIENCED SHORT PERIOD OF "AIRWAY BLOCKAGE" WHICH REQUIRED EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SEALGUARD ENDOTRACHEAL TUBES BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2009042301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention