BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 24037058 · Received January 12, 2026

    Report

    Report Number
    3038195011-2026-00050
    Event Type
    Injury
    Date Received
    January 12, 2026
    Report Date
    January 12, 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, FEVER AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED AND TREATED WITH INJECTION VANCOMYCIN (1GM, EVERY 48HRS, INTRAVENOUS DISCONTINUED) AND INJECTION CEFTAZIDIME (1GM, ONCE DAILY, INTRAVENOUS, DISCONTINUED) FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERED FROM PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96006 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H CATHETER UNKNOWN MANUFACTURER| DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| UNKNOWN VANTIVE DISPOSABLE PRODUCTS