BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2944192 · Received January 9, 2013

    Report

    Report Number
    1722139-2013-00029
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT TUBINGS INVOLVED HAVE BEEN DISCARDED, THERE WILL BE NO PRODUCT TO RETURN.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT THE ADMINISTRATION SET IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11344 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4174

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN