BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 24221347 · Received January 30, 2026

    Report

    Report Number
    3038195011-2026-00123
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 30, 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. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE SAME DAY AS THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH INJECTION VANCOMYCIN (1GM, EVERY 4TH DAYS, INTRAPERITONEAL, DISCONTINUED), AND INJECTION MEROPENEM (1GM, EVERY 14TH DAY, INTRAPERITONEAL, DISCONTINUED) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FOUR (4) DAYS AFTER HOSPITAL ADMISSION AND WAS RECOVERED FROM PERITONITIS. PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SHIFTED TO HEMODIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285012 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| PD CATHETER MEDCOM MANUFACTURER| UNKNOWN VANTIVE DISPOSABLE PRODUCTS