BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 24663527 · Received March 23, 2026

    Report

    Report Number
    3038195011-2026-00307
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    March 1, 2026
    Report Date
    March 23, 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 DAY AFTER THE PERITONITIS DIAGNOSIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (1GM, EVERY 5TH DAY, INTRAPERITONEAL, DISCONTINUED) AND INJECTION CEFTAZIDIME (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED) FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS RECOVERED FROM THE PERITONITIS; HOWEVER, THE PATIENT REMAINS HOSPITALIZED DUE TO OTHER INDICATION. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720001 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H CATHETER UNKNOWN MANUFACTURER.| DIANEAL 1.5% PD2.| DIANEAL 2.5% PD2.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.