BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25176079 · Received May 14, 2026

    Report

    Report Number
    1710034-2026-00511
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835164
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    ADDITIONAL INFORMATION: G.4. K183399; K243403. INVESTIGATION SUMMARY: ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. THIS IS THE 1ST COMPLAINT FOR CAP MISSING AND LEAKAGE FOR MATERIAL 383516 & BATCH 6021509. DEVICE HISTORY RECORD OF 6021509 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND DURING BUILT AND PACKAGING THIS LOT. A REVIEW OF THE APPLICABLE RISK DOCUMENTS INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP WAS MISSING AND BLOOD LEAKED. V HAD A CAP THAT WAS NOT ON THE CATHETER WHEN PLACING THE IV THE BLOOD FREE FLOWED OUT OF THE IV TUBING AND ALL OVER THE FLOOR. INJURIES OR ADVERSE EVENT: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291208 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6021509 00382903835164

    Patients

    Seq Age Sex Outcome Treatment
    1