BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 21429169 · Received February 20, 2025

    Report

    Report Number
    1416980-2025-00765
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 20, 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

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED AND TREATED WITH INJECTION VANCOMYCIN (1GR, EVERY 92 HOURLY), INJECTION CEFTAZIDIME (1GR, DAILY). AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME FROM THE EVENT WAS NOT REPORTED. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692593 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R DIANEAL 1.5%.| DIANEAL 2.5%.| EXTRANEAL 7.5%.