BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22906575 · Received August 27, 2025

    Report

    Report Number
    3030306055-2025-00215
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 3, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 AND B6. B5: UPON FOLLOW UP, IT WAS REPORTED THE PATIENT GOT DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM THE EVENTS ON AN UNKNOWN DATE. 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 DAY AFTER DIAGNOSIS, THE PATIENT WAS HOSPITALIZED AND TREATED WITH VANCOMYCIN INJECTION (1GM, ONCE IN 4 DAYS, INTRAPERITONEAL) AND CEFTAZIDIME INJECTION (1GM, ONCE DAILY, INTRAPERITONEAL) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS. PD THERAPY IS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366774 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention| H COVIDIEN PD CATHETER.| DIANEAL 1.5%.| DIANEAL 2.5%.| UNKNOWN VANTIVE PD DISPOSABLE.