BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1790762 · Received August 3, 2010

    Report

    Report Number
    2936999-2010-01048
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 4, 2010
    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 # 124075 IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. PLEASE REFER TO THE APPLICABLE 510K# K965132 FOR U.S. DISTRIBUTED PART. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THIS 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 TUBE DEVELOPED A CUFF LEAK DURING PT USE. THE CUSTOMER REPORTED TWO OCCURRENCES OF THE REPORTED DEFICIENCY ON ONE PT. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT 7.5MM HI-LO EVAC NASAL JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 2010049350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention