BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25224428 · Received May 19, 2026

    Report

    Report Number
    3038195011-2026-00514
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 19, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE SAME DAY AS PERITONITIS DIAGNOSIS, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM THE PERITONITIS AND THE ANTIBIOTICS WERE DISCONTINUED. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395407 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention CATHETER UNKNOWN MANUFACTURER| DIANEAL 2.5%, PD2| UNKNOWN VANTIVE DISPOSABLE PRODUCTS