BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2215874 · Received August 9, 2011

    Report

    Report Number
    1722139-2011-00191
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 8, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Removal / Correction Number
    Z-4770-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER 340-4114, LOT NUMBER D100319 IS CURRENTLY UNDER RECALL Z-1440-2011.

    Description of Event or Problem · 1

    CAREGIVER ALLEGED REPEATED AIR-IN-LINE ALARMS AND WAS UNABLE TO INFUSE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 D100319

    Patients

    Seq Age Sex Outcome Treatment
    1