BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22047946 · Received May 19, 2025

    Report

    Report Number
    1416980-2025-02918
    Event Type
    Injury
    Date Received
    May 19, 2025
    Report Date
    May 19, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE: NAKANO, T., KITAMURA, H., TSUNEYOSHI, S., TSUCHIMOTO, A., TORISU, K., TSUJIKAWA, H., KAWANISHI, H., TSURUYA, K., KITAZONO, T. ¿PREDICTORS OF ENCAPSULATED PERITONEAL SCHLEROSIS IN PATIENTS UNDERGOING PERITONEAL DIALYSIS USING NEURTRAL-PH DIALYSATE¿. CLINICAL AND EXPERIMENTAL NEPHROLOGY. (2025) 29:212-220. HTTPS://DOI.ORG/10.1007/S10157-024-02565-9. 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 SEVERE PERITONITIS. THE CAUSE, HOSPITALIZATION, LABORATORY TEST AND PATIENT OUTCOME WERE NOT REPORTED. PD THERAPY WAS DISCONTINUED AND PD CATHETER WAS REPLACED. DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129838 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other DIANEAL| EXTRANEAL| REGUNEAL| UNKNOWN PD CATHETER