BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2233038 · Received July 26, 2011

    Report

    Report Number
    1722139-2011-00130
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY ONGOING. WHEN INVESTIGATION IS COMPLETE, A FOLLOW UP WITH THE RESULTS WILL BE SUBMITTED. THIS LOT NUMBER IS NOT INCLUDED IN THE RECALL FOR CURLIN ADMINISTRATIVE SETS.

    Description of Event or Problem · 1

    INFO RECEIVED ALLEGES THE USER RECEIVED AN 'AIR IN LINE' ALARM AND MICROBUBBLES HAD FORMED IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 3404114` CF1103401

    Patients

    Seq Age Sex Outcome Treatment
    1 CURLIN INFUSION PUMP