BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25008536 · Received April 27, 2026

    Report

    Report Number
    3038195011-2026-00418
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 27, 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. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEROPENEM INJECTION (250MG, FOUR TIMES A DAY, INTRAPERITONEAL, DISCONTINUED AFTER 14 DAYS) AND VANCOMYCIN INJECTION (500MG, EVERY 72 HOURLY, INTRAPERITONEAL, DISCONTINUED AFTER 14 DAYS) FOR PERITONITIS. EIGHT DAYS AFTER HOSPITAL ADMISSION, THE PATIENT WAS DISCHARGED AND RECOVERED FROM THE PERITONITIS. PD THERAPY WAS ONGOING. IT WAS REPORTED 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
    302457 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H DIANEAL PD2 2.5%| MEDI-TECH PD CATHETER| UNKNOWN VANTIVE PD DISPOSABLE