BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23771525 · Received December 10, 2025

    Report

    Report Number
    1710034-2025-01931
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 19, 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
    KY, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ANNEX E AND F CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINTS OF BLOOD CONTROL FAILURE AND THE NEEDLES PULLING THE IV CATHETER DURING RETRACTION COULD NOT BE CONFIRMED FROM THE THREE SHIELDED NEEDLES THAT WERE PROVIDED FOR INVESTIGATION FROM LOTS 5120110 AND 5210669. THE IMPLICATED 18G INSYTE AUTOGUARD IV CATHETERS WERE NOT RETURNED WITH THE NEEDLES. THE RETURNED SAMPLES EXHIBITED EVIDENCE OF USE. NO DAMAGE OR DEFECTS WERE IDENTIFIED FROM A VISUAL EXAMINATION. A FUNCTIONAL TEST REVEALED THAT THE NEEDLES FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. NO EVIDENCE OF A LEAK WAS IDENTIFIED ON THE RETURNED SAMPLE. ALTHOUGH THE RETURNED SAMPLE AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, 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. COMPLAINTS RECEIVED ABOUT THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    BLOOD CONTROL FAILURE. AS NEEDLE IS RETRACTING IT PULLS THE CATHETER OUT. NURSES ARE HOLDING CATHETER TO KEEP IN PLACE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170848 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5210669 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown