BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS

    MDR report key: 24093801 · Received January 16, 2026

    Report

    Report Number
    9610847-2026-00013
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 20, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835966
    PMA / PMN Number
    K233529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510K PROVIDED- K250682. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 9 USED PHYSICAL SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT VISUAL INSPECTION UNDER MAGNIFICATION SHOWED NO DAMAGE WAS OBSERVED. A LEAK TEST WAS PERFORMED ON ALL SAMPLES AS THEY WERE RECEIVED AND ALL SAMPLES PASSED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    LEAKING HAPPENING WHILE FLUSHING AT THE CONNECTION OF NEXIVA HUB AND MAXZERO. A FEW DROPLETS OF SALINE LEAK OUT. POTENTIAL EXPOSURE TO BLOOD. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR HEALTHCARE WORKER. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT 29-12-2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585390 NEXIVA DIFFUSICS PERIPHERAL IV CATHETERS FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5281696 00382903835966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown