BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 22849640 · Received August 20, 2025

    Report

    Report Number
    1710034-2025-01381
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 30, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383536 AND LOT NUMBER 5120888. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 20 GA IV CATHETER APPEARED TO BE DEFECTIVE. UPON RN ATTEMPTING TO START IV TO PATIENT'S LAC AND AFTER ATTACHING MALE ADAPTER TO DRAW PATIENT LAB WORK, RN REPORTS PATIENT'S BLOOD WAS COMING OUT OF THE SIDE OF THE IV CATHETER TUBING AND ENDED UP ALL OVER THE EXAM ROOM FLOOR.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374533 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120888 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown