BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 22668279 · Received July 30, 2025

    Report

    Report Number
    3030306055-2025-00144
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 30, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 INJECTION CEFTAZIDIME (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED AFTER 14DAYS) AND INJECTION CEFAZOLIN (1GM, ONCE DAILY, INTRAPERITONEAL, DISCONTINUED AFTER 14DAYS) FOR PERITONITIS. THE PATIENT WAS DISCHARGED THREE DAYS AFTER HOSPITAL ADMISSION. ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. 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
    445750 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H DIANEAL 2.5% PD2| NON-VANTIVE CATHETER