BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 3091542 · Received April 16, 2013

    Report

    Report Number
    3091542
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ICU MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED POST-OP, TWO CLAVE CONNECTORS ATTACHED TO 4- WAY STOPCOCK. WHEN CLAVES WERE REMOVED THEY HAD BROKEN OFF INSIDE THE STOPCOCK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?YES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163793 CLAVE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR BRAUN MEDICAL DISCOFIX