BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23574308 · Received November 17, 2025

    Report

    Report Number
    1710034-2025-01790
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 15, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE COMPLAINT OF SLOW RETRACTION AND LEAKAGE BEYOND THE SEPTUM COULD NOT BE CONFIRMED FROM THE ONE SEALED UNIT FROM LOT 5171717 RETURNED WITH AN ADDITIONAL EMPTY PACKAGE FROM THE SAME LOT. A FUNCTIONAL TEST OF THE RETURNED SAMPLE REVEALED THAT THE NEEDLE WOULD FULLY RETRACT, AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. A LEAK TEST OF THE IV CATHETERS REVEALED NO LEAKS FOR LOT 5171717. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING-RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    SLOW SAFETY & SPILL BLOOD AFTER PULLING OFF WITH A SYRINGE. WHEN THE IV ACCESSES THE VEIN THERE IS A BACKFLOW OF BLOOD OUT OF THE BACK OF THE CATHETER. I HAVE NOT BEEN KEEPING TRACK OF EXACT DATES THAT THESE ITEMS HAVE COME TO ME BUT CAN DO SO MOVING FORWARD. THERE HAS BEEN NO PATIENT/STAFF HARM AT THIS TIME. THE MESS THAT WE HAVE ENCOUNTERED IS SIGNIFICANT AS WELL AS THE STRESS WE ARE CAUSING FOR THE PATIENTS AS THEY SEE THE BLOOD ALL OVER THE NURSES AND THE BED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288841 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5171717 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown