BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2253355 · Received August 3, 2011

    Report

    Report Number
    1722139-2011-00184
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Removal / Correction Number
    Z-1440-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER 340-4114, LOT NUMBER CRF 10163003 IS CURRENTLY UNDER RECALL Z-1440-2011.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE ADMINISTRATION SETS HAVE AIR IN LINE ISSUES WHEN THERE IS NO AIR IN THE BAG OR LINE. THE ACCOUNT ALLEGES AN AIR IN LINE ALARM WILL OCCUR BETWEEN 30 MINUTES AND ONE HOUR. THE ACCOUNT ALLEGES THERE ARE MICROBUBBLES IN THE SOFT CHAMBER OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 CRF 10163003

    Patients

    Seq Age Sex Outcome Treatment
    1