BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 4023072 · Received August 15, 2014

    Report

    Report Number
    4023072
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 15, 2014
    Manufacturer
    IVERA MEDICAL
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUROS CAP BROKE APART. LITTLE GREEN RING STAYED ON THE IV PORT WHEN RN TOOK THE CAP OFF. THIS APPARENTLY HAPPENED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490192 CUROS SET, ADMINISTRATION, INTRAVASCULAR LKB IVERA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *