BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2831499 · Received October 11, 2012

    Report

    Report Number
    1722139-2012-01013
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 10, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED FOR LOT NUMBER CF1207514 AND FOUND ZERO DEFECTS FOR THIS LEAK ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT DURING TESTING, THE TUBING IS LEAKING FROM THE WHITE POINTY END AT THE TOP WHERE THE TUBING GOES INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 CF1207514

    Patients

    Seq Age Sex Outcome Treatment
    1