BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC

    MDR report key: 22698172 · Received August 4, 2025

    Report

    Report Number
    22698172
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 25, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STOPCOCK DEVICE FOUND TO BE LEAKING WITH IMPORTANT FLUIDS RUNNING THROUGH LINE. WE HAVE HAD 3 OCCURRENCES IN THE PAST WEEK THAT WE IDENTIFIED THERE WAS A HOLE AT THE STOPCOCK, AND THE OTHERS WERE FOUND TO BE CRACKED. WE HAVE REACHED OUT TO THE SUPPLIER MEDLINE AND THEY HAVE TAKEN THE PRODUCTS AND ARE LAUNCHING AN INVESTIGATION. WE NOW HAVE A SUBSTITUTE PRODUCT AVAILABLE. WILL WORK WITH NICU [NEONATAL INTENSIVE CARE UNIT] TEAM, MEDLINE AND CSS [CLINICAL STABILIZATION SERVICES] TO FIGURE OUT NEXT STEPS. PRODUCT INFORMATION: NAMIC STOPCOCK, REF-70015003, LOT-0000109868.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230827 NAMIC ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS DTL MEDLINE INDUSTRIES, INC. 70015003 0000109868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown