BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2100481 · Received May 17, 2011

    Report

    Report Number
    2936999-2011-00330
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 17, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 316-10 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 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 REC'D A REPORT WHERE IT WAS CLAIMED THAT THE TUBE DEVELOPED A LEAK IN THE CUFF DURING PT USE. THE CALLER REPORTED THE LEAK WAS DETECTED DURING PRETESTING, BUT THE TUBE WAS USED ON PT DESPITE OBSERVED LEAK DURING PRETESTING. THE TUBE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT HI-LO TRACHEAL TUBE JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 2008077078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention