BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22897503 · Received August 26, 2025

    Report

    Report Number
    3030306055-2025-00204
    Event Type
    Injury
    Date Received
    August 26, 2025
    Report Date
    August 26, 2025
    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, ABDOMINAL PAIN AND DIFFICULTY BREATHING. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705002 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H DIANEAL 1.5% PD2.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.