BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 25145164 · Received May 11, 2026

    Report

    Report Number
    1710034-2026-00502
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835386
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    IT WAS REPORTED THAT THE TUBING LEAKED AT THE ADAPTER-TUBING JUNCTION. "IT WAS REPORTED THAT TODAY ULTRASOUND GUIDED IV WAS INSERTED IN THE ABOVE PATIENT. THE IV WAS CORRECTLY PLACED, BUT AFTER PLACING THE IV THE IV SYSTEM TURNED OUT TO BE LEAKY. BLOOD LEAKS UP THE END OF THE TUBE, JUST BELOW THE JUNCTION WHERE FLUIDS CAN BE ADMINISTERED.". "THE RISK FOR THE PATIENT IS THAT THE CHANCE OF A RUNNING IV IS SMALLER, BECAUSE THESE PATIENTS HAD ALREADY BEEN PRICKED WITH THE ULTRASOUND AND IF THE LEAKAGE WERE NOT SEEN, MEDICATION WOULD NOT REACH THE PATIENT. ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604185 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4276209 00382903835386

    Patients

    Seq Age Sex Outcome Treatment
    1