BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2228382 · Received August 24, 2011

    Report

    Report Number
    1722139-2011-00260
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1445-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER 340-4128V IS CURRENTLY UNDER RECALL Z-1445-2011. LOT D020024 IS NOT PART OF THAT RECALL.

    Description of Event or Problem · 1

    INFORMATION 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 340-4128V D020024

    Patients

    Seq Age Sex Outcome Treatment
    1