BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25046265 · Received April 30, 2026

    Report

    Report Number
    3038195011-2026-00433
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 15, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, B6 AND H6. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE PREVIOUSLY REPORTED PERITONITIS WAS NOT CONFIRMED AND THE PATIENT EXPERIENCED CLOUDY PD EFFLUENT AND FEVER. HEPARIN WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM CLOUDY FLUID AND FEVER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED SUSPECTED PERITONITIS MANIFESTED BY CLOUDY PD EFFLUENT AND FEVER. THE CAUSE OF PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS NOT TREATED WITH ANTIBIOTICS FOR THE EVENTS; HOWEVER, THE PATIENT RECEIVED HEPARIN INJECTION (2000IU, ONCE DAILY, INTRAPERITONEAL, ONGOING). AT THE TIME OF THIS REPORT, THE SUSPECTED PERITONITIS OUTCOME WAS UNKNOWN. THE PATIENT RECOVERED FROM CLOUDY EFFLUENT AND FEVER. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138335 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other DIANEAL 2.5%| TENCHKOFF PD CATHETER| UNKNOWN VANTIVE PD DISPOSABLE