BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 23038906 · Received September 12, 2025

    Report

    Report Number
    3030306055-2025-00262
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 17, 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

    ADDITIONAL INFORMATION: B5. CORRECTION: D1, G1. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT CHANGED TRANSFER SET AFTER 8 MONTHS. D1: THE REPORTED PRODUCT IS AN UNKNOWN VANTIVE TRANSFER SET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 DESCRIBED TO BE "PATIENT HAS NOT CHANGED THE TRANSFER SET FOR A LONG TIME AND CONSTIPATION". THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND CONSTIPATION. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. FROM THE SAME DAY OF PERITONITIS DIAGNOSIS, THE PATIENT WAS TREATED WITH AMIKACIN INJECTION (100MG, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED), VANCOMYCIN INJECTION (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED) AND MEROPENEM INJECTION (500MG, TWICE A DAY, INTRAPERITONEAL, DISCONTINUED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT RECOVERED FROM THE EVENTS. PD THERAPY IS ONGOING. IT WAS NOT REPORTED WHETHER THE PATIENT AND CAREGIVER WERE RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170638 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention DIANEAL 2.5%| EXTRANEAL 7.5%| UNKNOWN PD CATHETER| UNKNOWN VANTIVE PD DISPOSABLE