BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 23088761 · Received September 18, 2025

    Report

    Report Number
    3030306055-2025-00299
    Event Type
    Injury
    Date Received
    September 18, 2025
    Report Date
    September 18, 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

    THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER VANTIVE LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS NOT FURTHER DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR THE EVENT ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANTIBIOTIC TREATMENT FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERED FROM PERITONITIS. PD THERAPY WAS DISCONTINUED, THE PD CATHETER WAS REMOVED, AND THE PATIENT WAS SHIFTED TO HEMODIALYSIS (ONGOING). IT WAS REPORTED THAT THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2841402 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization COVIDIEN PD CATHETER| DIANEAL 1.5%| DIANEAL 2.5%| UNKNOWN VANTIVE PD DISPOSABLE