BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 4253190 · Received September 21, 2014

    Report

    Report Number
    4253190
    Event Type
    Malfunction
    Date Received
    September 21, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 21, 2014
    Manufacturer
    IVERA MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO PUT A GREEN CUROS CAP ON A LINE, IT BROKE AND THE NURSE HAD TO PRY THE BROKEN PIECE OFF THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586208 CUROS SET, ADMINISTRATION, INTRAVASCULAR FPA IVERA MEDICAL 002-250 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR