BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL INC MICROCLAVE CONNECTOR

    MDR report key: 3187785 · Received June 19, 2013

    Report

    Report Number
    MW5030637
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ICU MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TO HAVE AN AGITATED BUBBLE STUDY TEST. RN ATTACHED THE STOPCOCK/SYRINGE SET UP ONTO THE ICU MEDICAL INC. MICROCLAVE CONNECTOR THAT WAS ON THE IV CATHETER. RN WAS ABLE TO COMPLETE AGITATION PROCESS FROM THE SALINE SYRINGE TO THE SALINE SYRINGE BUT WHEN SHE SWITCHED THE STOPCOCK TO ADMINISTER THE AGITATED SALINE TO THE PT, SHE WAS UNABLE TO FLUSH IT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279266 ICU MEDICAL INC MICROCLAVE CONNECTOR MICROCLAVE CONNECTOR FPA ICU MEDICAL INC RL=15185 2537747
    279267 ICU MEDICAL INC MICROCLAVE CONNECTOR MICROCLAVE CONNECTOR FPA ICU MEDICAL INC RL=15185 2621285

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other