BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25151276 · Received May 12, 2026

    Report

    Report Number
    3038195011-2026-00485
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 12, 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

    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. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH CEFTAZIDIME INJECTION (500 MG, ONCE DAILY, INTRAPERITONEAL, ONGOING) AND AMIKACIN INJECTION (150 MG, ONCE DAILY, INTRAPERITONEAL, ONGOING) FOR PERITONITIS. SEVEN DAYS AFTER THE EVENT ONSET, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT RECOVERED FROM THE EVENTS. PD THERAPY IS ONGOING. IT WAS REPORTED RETRAINING ON THE PROPER ASEPTIC TECHNIQUE WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533543 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R DIANEAL 1.5%| DIANEAL 2.5%| UNKNOWN PD CATHETER| UNKNOWN VANTIVE PD DISPOSABLE