BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2251692 · Received August 31, 2011

    Report

    Report Number
    1722139-2011-00289
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER 340-4128 LOT CF1022207 IS CURRENTLY UNDER RECALL Z-1444-2011.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE CUSTOMER EXPERIENCED AIR-IN-LINE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4128 CF1022207

    Patients

    Seq Age Sex Outcome Treatment
    1