BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 24060243 · Received January 13, 2026

    Report

    Report Number
    3038195011-2026-00066
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 13, 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 EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR PERITONITIS EVENT. THE SAME DAY AS PERITONITIS ONSET, THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (1GM, EVERY 5TH DAY, INTRAPERITONEAL, DISCONTINUED AFTER SEVEN DAYS) AND INJECTION CEFTAZIDIME (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED AFTER SEVEN DAYS) FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS DISCONTINUED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113703 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention CATHETER UNKNOWN MANUFACTURER.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE PD DISPOSABLE PRODUCTS.