BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 23183339 · Received September 30, 2025

    Report

    Report Number
    3030306055-2025-00331
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 17, 2025
    Report Date
    October 7, 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

    ADDITIONAL INFORMATION: A2, B5, B6, B7 AND H6. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE PERITONITIS WAS BACTERIA. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH LEVOFLOXACIN (INTRAVENOUS, DISCONTINUED) FOR BACTERIAL PERITONITIS. IT WAS REPORTED THAT THE CATHETER WAS REMOVED "DUE TO BIOFILM IN THE CATHETER." IT WAS REPORTED THAT THE PATIENT RECOVERED FROM PERITONITIS 30 DAYS AFTER EVENT ONSET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 EFFLUENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED "FOR ABOUT FOUR WEEKS' AND TREATED WITH UNSPECIFIED ANTIBIOTICS. PD THERAPY WAS DISCONTINUED AND THE PD CATHETER WAS REMOVED. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106287 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R EXTRANEAL.| KAGUYA AUTOMATED PD SYSTEM.| REGUNEAL LCA 1.5.