BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARVELOUS STOPCOCK FOR IVS

    MDR report key: 10118487 · Received June 3, 2020

    Report

    Report Number
    MW5094826
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 15, 2020
    Report Date
    June 1, 2020
    Manufacturer
    ELCAM MEDICAL ACAL
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CRACK WAS NOTED IN THE ANTIREFLUX PORT OF THE STOPCOCK. STOPCOCK AND TUBING CHANGED VIA STERILE TECHNIQUE IMMEDIATELY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578820 MARVELOUS STOPCOCK FOR IVS STOPCOCK, I.V. SET FMG ELCAM MEDICAL ACAL 3738837

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA