BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 23952995 · Received January 3, 2026

    Report

    Report Number
    1710034-2025-02010
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    December 14, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903836420
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383642 AND LOT NUMBER 5093794. 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

    CATHETER HAS SPLIT OFF OF THE SIDE OF THE STYLET AS IT ENTERED THE VEIN- ELICITING PAIN. USER REMOVED CATHETER FROM PACKAGING, ENSURED THAT THE STYLET AND CATHETER MOVED EASILY- CATHETER APPEARED SAFE TO USE. CANNULATION WAS STRAIGHTFORWARD UNTIL PAIN ELICITED. REMOVED AND ENSURED PT WAS SAFE. REMOVED CATHETER- FOUND THAT THE CATHETER WAS SPLIT AWAY FROM THE STYLET.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14664 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5093794 00382903836420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown