BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 25127606 · Received May 8, 2026

    Report

    Report Number
    2314912-2026-00281
    Event Type
    Injury
    Date Received
    May 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00085412008776
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, H6, AND H11. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE TRANSFER SET DID NOT EXCEED 6 MONTHS OF USE. H11: THE ONE (1) ACTUAL DEVICE WAS PROVIDED FOR EVALUATION. THE SAMPLE WAS RETURNED IN WET CONDITION WITH TWIST CLAMP IN CLOSED POSITION AND A MINI CAP ATTACHED. VISUAL INSPECTION BY NAKED EYE AND FUNCTIONAL TESTING WERE PERFORMED WITH NO ISSUES OBSERVED. AN ACCEPTABLE FLUID FLOW THROUGH THE SET WAS NOTED DURING CLEAR PASSAGE TESTING. THE RETURNED SAMPLE MET SPECIFICATIONS. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE WAS REPORTED TO BE "DUE TO DEFECTIVE SIX MONTH UNIT" (TRANSFER SET). IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. IT WAS REPORTED THAT THE TRANSFER SET WAS REPLACED ON AN UNSPECIFIED DATE AND DID NOT EXCEED SIX MONTHS OF USE. PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15897 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA H24C13090 00085412008776

    Patients

    Seq Age Sex Outcome Treatment
    1