BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 2412604 · Received January 9, 2012

    Report

    Report Number
    2412604
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 9, 2012
    Manufacturer
    IVERA MEDICAL CORPORATION
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE PUT THE CUROS PROTECTOR COVERS ON THE ALL THE PRIMARY PORTS. SHE SPIKED THE IV SOLUTION AND PRIMED THE TUBING. ONE OF THE CUROS COVERS FELL APART. THE TUBING WAS NOT ATTACHED TO THE PATIENT AT THE TIME THE COVER BROKE.THIS IS THE FIRST I HAVE HEARD OF THIS INCIDENT. ANOTHER CUROS PORT PROTECTOR WAS USED FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUROS CUROS PORT PROTECTOR LKB IVERA MEDICAL CORPORATION * IMC250-072211

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES