BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22687196 · Received August 1, 2025

    Report

    Report Number
    3030306055-2025-00147
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 1, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 AND ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE SAME DAY AS THE PERITONITIS DIAGNOSIS, THE PATIENT WAS TREATED WITH INJECTION HEPARIN (1000IU, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED), INJECTION MAGNEX FORTE (1.5 G, TWICE A DAY, INTRAVENOUS, DISCONTINUED) AND INJECTION CIPLOX (200 MG, ONCE DAILY, INTRAVENOUS, DISCONTINUED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT RECOVERED FROM PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223468 NI : SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention CATHETER MANUFACTURER NAME: UNKNOWN| DIANEAL 1.5% PD2| DIANEAL 2.5% PD2| UNKNOWN VANTIVE DISPOSABLE PRODUCTS