BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25124398 · Received May 8, 2026

    Report

    Report Number
    3038195011-2026-00466
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 8, 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

    THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED CLOUDY EFFLUENT IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO SPECIFIC INFECTION REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. 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 CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF THE EVENTS WAS NOT REPORTED. THE SAME DAY AS EVENTS BEGAN, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. TREATMENT FOR THE EVENTS WAS NOT REPORTED. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER HOSPITAL ADMISSION. ON AN UNKNOWN DATE, THE PATIENT WAS RECOVERED FROM CLOUDY EFFLUENT AND ABDOMINAL PAIN. IT WAS REPORTED THAT THE DAY AFTER EVENTS BEGAN, PD THERAPY WAS DISCONTINUED, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS SHIFTED TO HEMODIALYSIS (ONGOING). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337822 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Hospitalization DIANEAL 2.5% PD2.| EXTRANEAL 7.5% PD2.| TENKHOFF PD CATHETER.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.