BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25321902 · Received May 28, 2026

    Report

    Report Number
    1710034-2026-00562
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K183399; K243403. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    A RN WAS COMPLETING AN IV INSERTION ON A PATIENT FOR A CT SCAN. NURSE NOTICED BLOOD COMING FROM THE IV CATHETER TUBING. THERE WAS A HOLE IN THE TUBING WHERE THE TUBING IS CONNECTED TO THE NEEDLE PORTION. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363518 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5329070 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1