BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2891271 · Received November 29, 2012

    Report

    Report Number
    1722139-2012-01194
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED. DHR WAS PERFORMED AND NON-DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT THE ADMINISTRATION SET IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4130 CF1218810

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN