BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24944372 · Received April 21, 2026

    Report

    Report Number
    1710034-2026-00444
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 22, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT 5329070 REGARDING ITEM #383536. DEVICE HISTORY RECORD OF LOT NUMBER 5329070 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.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAKAGE OCCURRED. "IV START WORKED FINE, ONCE RN WENT TO FLUSH IV, IV HUB STARTED LEAKING DESPITE HUBS BEING TIGHTENED. IV HAD TO BE EXCHANGED FOR NEW ONE. AFTER IV REMOVED AND FURTHER INVESTIGATED, IV APPEARED TO HAVE BEEN INDENTED". "NEEDED A NEW IV".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481408 NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5329070 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1