BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 25008053 · Received April 27, 2026

    Report

    Report Number
    3038195011-2026-00413
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 25, 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 FURTHER NOT DESCRIBED. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE SAME DAY AS EVENT ONSET, THE PATIENT WAS TREATED WITH INJECTION AMIKACIN (500MG, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED AFTER THREE DAYS) AND INJECTION VANCOMYCIN (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED AFTER THREE DAYS) FOR PERITONITIS. FOUR DAYS AFTER EVENT ONSET, THE PATIENT WAS RECOVERED FROM PERITONITIS. PD THERAPY WAS 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
    319545 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention DIANEAL 2.5% PD2.| EXTRANEAL 7.5% PD2.| MEDCOM PD CATHETER.| UNKNOWN VANTIVE DISPOSABLE PRODUCTS.