BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2053369 · Received March 15, 2011

    Report

    Report Number
    1722139-2011-00035
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED FOR EVAL. ONCE PRODUCT IS RECEIVED, A F/U WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TEN SETS USED IN BIOMED TESTING LEAKED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 CF1022903

    Patients

    Seq Age Sex Outcome Treatment
    1