BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23087577 · Received September 18, 2025

    Report

    Report Number
    3014732157-2025-00991
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 3, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030108
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FINDINGS: NO SAMPLE OR PICTURE AVAILABLE FOR ANALYSIS. CUSTOMER COMPLAINT CANNOT BE VALID. ROOT CAUSE: THE SECONDARY PORT IS LOCKED AND NOT AVAILABLE FOR USE IN SET-0021-25, THE ONLY LINE TO BE USED IS THE PRIMARY. BASED ON ALL KNOWN INFORMATION, THERE WAS NO MALFUNCTION OR MIS-ASSEMBLY OF THE SET. THE ISSUE IS ATTRIBUTED TO CUSTOMER TRAINING/PRODUCT KNOWLEDGE. CURRENT PROCESS CONTROLS DETECTION: 100% VISUAL INSPECTION. CODE NO.: SET-0021-25. BATCH NO.: FA25E12237. EXCEPTION GENERATED: THE BATCH RECORD FA25E12237 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. QUALITY TEST RESULTS: THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: DEAD-ENDER ON S PORT MISSING. THEREFORE, WHEN THE SET WAS PRIMED THE MEDICATION SPILLED OUT OF THE S PORT ONTO THE FLOOR. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840381 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, SINGLE-INLET, LOW-SORBING FPA FRESENIUS KABI USA LLC SET-0021-1 FA25E12237 00811505030108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown