BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE-N AUTOGUARD

    MDR report key: 23799389 · Received December 14, 2025

    Report

    Report Number
    1710034-2025-01946
    Event Type
    Malfunction
    Date Received
    December 14, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818112
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381811 AND LOT NUMBER 5191878. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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 NEW INFORMATION.

    Description of Event or Problem · 0

    PT WAS RECEIVING 2ND IV ACCESS ATTEMPT DUE TO INITIAL UNSUCCESSFUL ATTEMPT. IV ACCESS USING 24 GAUGE INSYTE AUTOGUARD 0.75 WAS ATTEMPTED. DURING ATTEMPT SS HAD FLASH AND WAS ATTEMPTING TO THREAD CANNULA. SS WAS UNABLE TO THREAD CANNULA. SS STATES THAT THEY HIT FLASH IMMEDIATELY WITH 0 READJUSTMENT OF NEEDLE REQUIRED. AFTER BEING UNABLE TO THREAD, A BUMP WAS NOTED TO IV SITE. NEEDLE WAS NOT RETRACTED AND CANNULA WAS REMOVED WITH NEEDLE IN PLACE. SS NOTED THAT NEEDLE HAD PUNCTURED TOP 1/4 OF CANNULA. CANULA WAS REMOVED INTACT. (B)(6) 2025: THERE WERE NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016063 INSYTE-N AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5191878 00382903818112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown