BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 19822341 · Received July 24, 2024

    Report

    Report Number
    3014732157-2024-00517
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 15, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D UPDATED TO ALIGN WITH THE INFORMATION LISTED ON GUDID.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: ONE ADMINISTRATION SET WITH CLOGGED SECONDARY PORT WERE REPORTED BY TEST ENGINEERING. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: SET-0013 CLOGGED ADMIN SET AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    ONE ADMINISTRATION SET WITH CLOGGED SECONDARY PORT WAS FOUND FROM LOT 3005684. THE SECONDARY PORT WAS INSPECTED USING A SCIENSCOPE XT-2000 MICROSCOPE. THE SET WAS INSPECTED AND FOUND TO HAVE A NON-SLIT VALVE. THIS IMPROPER VALVE SLITTING IS A MANUFACTURING ASSEMBLY ERROR THAT EXPLAINS THE CLOGGED SECONDARY PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365085 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA LLC SET-0013-1 3005684 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown