BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION ADMINISTRATION SET

    MDR report key: 4270116 · Received November 12, 2014

    Report

    Report Number
    MW5039141
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 12, 2014
    Manufacturer
    ,OOG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE REPORTS OF ONE LOT OF PRODUCT CAUSING INFUSION PUMP ERRORS. DATES OF USE: (B)(6) 2014 - (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728023 CURLIN INFUSION ADMINISTRATION SET INFUSION SET, 1.2 MICRON FILTER FRN ,OOG CF1420502

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR