BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2233058 · Received July 26, 2011

    Report

    Report Number
    1722139-2011-00140
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1444-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT 340-4128, LOT CF1018802 IS CURRENTLY UNDER RECALL #Z-1444-2011.

    Description of Event or Problem · 1

    INFO RECEIVED ALLEGES PTS WERE RECEIVING EXCESSIVE AIR IN THE LINE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4128 CF1018802

    Patients

    Seq Age Sex Outcome Treatment
    1 CURLIN INFUSION PUMP