BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    MDR report key: 22589119 · Received July 24, 2025

    Report

    Report Number
    MW5173233
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ASSET MEDIKAL TASARIM SAN. TIC. A.S.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY INFUSION COMPANY HAS RECENTLY REPLACED MY USUAL ICU MEDICAL CLAVE CONNECTORS (REF C1000) WITH NEUTRART® CONNECTORS (REF A1010N), MANUFACTURED BY ASSET MEDICAL AND DISTRIBUTED BY (B)(4). I USE THESE CLAVES FOR MY CENTRAL LINE. I HAVE REPEATEDLY OBSERVED THAT THE VALVE ON THE A1010N FAILS TO RESEAL PROPERLY AFTER DISCONNECTION. THE CENTER PORT REMAINS VISIBLY DEPRESSED AND DOES NOT RETURN TO A CLOSED STATE, WHICH I BELIEVE POSES A SERIOUS CONTAMINATION AND INFECTION RISK. I HAVE NOT EXPERIENCED THIS ISSUE WITH THE ICU MEDICAL CONNECTORS. I AM CONCERNED THAT THIS REPRESENTS A DEVICE DEFECT THAT COULD COMPROMISE STERILITY OF VASCULAR ACCESS LINES. THE REF A1010N DEVICE WAS CLEARED UNDER 510(K) K222889, BUT BASED ON FIRSTHAND USE, I BELIEVE THIS MODEL MAY WARRANT FURTHER POST-MARKET REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988679 FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA ASSET MEDIKAL TASARIM SAN. TIC. A.S. A1010N

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female