BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 4201094 · Received September 16, 2014

    Report

    Report Number
    1722139-2014-00144
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAL AT 09/15/2014.

    Description of Event or Problem · 1

    INFO INDICATES LEAKAGE IN CURLIN ADMINISTRATION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572606 CURLIN ADMINISTRATION SET ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 CF1404514

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR MORPHINE