BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX

    MDR report key: 22621071 · Received July 25, 2025

    Report

    Report Number
    9611369-2025-00105
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 2, 2025
    Report Date
    August 19, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FJI
    UDI-DI
    07332414102760
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED A BLACK PARTICLE INSIDE THE DIALYZER BLOOD HEADER SCREWED CONNECTOR. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS VERIFIED. THE IDENTIFICATION AND ORIGIN OF THE PARTICLE WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "FOREIGN MATTER" WAS OBSERVED IN THE SCREWED CONNECTOR OF A POLYFLUX 170H PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351644 POLYFLUX DIALYZER, CAPILLARY, HOLLOW FIBER FJI VANTIVE US HEALTHCARE LLC NA 5-4504-H-01 07332414102760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.