BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET IV EXTENSION 60-IN MICROBORE W/MICROCLAVE

    MDR report key: 20723120 · Received November 19, 2024

    Report

    Report Number
    20723120
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE NURSE WENT TO CHANGE OUT THE PGE (PROSTAGLANDIN E1) SYRINGE AND NOTICED THAT THE BONDED MICROCLAVE'S LINE WAS STILL IN THE DEPRESSED POSITION. NEW TUBING WAS PRIMED WITH SYRINGE. PLEASE NOTE THAT THERE HAVE BEEN PREVIOUS EXTENSION SETS' MICROCLAVES THAT WOULD NOT RETURN TO POSITION AFTER USE(STICKING.) THESE EXTENSION SETS ARE NOT PART OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307519 SET IV EXTENSION 60-IN MICROBORE W/MICROCLAVE STOPCOCK, I.V. SET FMG ICU MEDICAL, INC. MC330363

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Male