BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1935993 · Received December 9, 2010

    Report

    Report Number
    2936999-2010-01360
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K082520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART (B)(4) IS NOT DISTRIBUTED IN THE US; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. APPLICABLE 510K# FOR US DISTRIBUTED PART K082520. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FOR THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY REC'D A REPORT WHERE IT WAS CLAIMED THAT CUFF LEAKED DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. THIS REPORT IS ASSOCIATED TO THE SECOND OCCURRENCE REPORTED ON MFR# (B)(4) / 2936999-2010-01335.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SEALGUARD EVAC ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEALTHCARE 2006126776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention