BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS

    MDR report key: 24716825 · Received March 30, 2026

    Report

    Report Number
    9610847-2026-00142
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 17, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835904
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PICTURES WERE RECEIVED TO PERFORM INVESTIGATION. IT IS RECOMMENDED TO PROVIDE A SAMPLE EXHIBITING THE REPORTED DEFECT FOR EVALUATION. THE MANUFACTURING RECORDS FOR THIS BATCH HAS BEEN REVIEWED AND NOTHING EXTRAORDINARY OCCURRED DURING THE MANUFACTURING PROCESS RELATED TO THIS FAILURE MODE. INTERNAL QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES BUT ISSUES LIKE THIS ARE NOT DETECTED WHICH MEANS LOW OCCURRENCE. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY.

    Additional Manufacturer Narrative · 0

    G.4. K173354; K250682. 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 NEXIVA DIFFUSICS LEAKED. DATE OF INCIDENT: (B)(6) 2026. LEVEL OF HARM: TEMPORARY HARM. NO SERIOUS HARM WAS REPORTED. INCIDENT DETAILS: STAFF NURSE WENT TO PLACE PIV, UPON INITIAL POKE, BLOOD BEGAN LEAKING THROUGH THE IV CANNULA AT THE BASE. IV ATTEMPT WAS ABORTED AND 2ND IV ATTEMPT WAS GAINED. WHO WAS AFFECTED? PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305130 NEXIVA DIFFUSICS PERIPHERAL IV CATHETERS FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5302322 00382903835904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown