BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25148836 · Received May 12, 2026

    Report

    Report Number
    1710034-2026-00501
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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 23RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT 5120110 REGARDING ITEM #382544. DHR FOR LOT NUMBER 5120110 HAS BEEN REVIEWED. NO QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. 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. K201075; K251654 H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, IL WAS USED AS THE STATE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. "AFTER DEPRESSING THE WHITE SAFETY BUTTON ON THE IV START NEEDLE IN ORDER FOR THE NEEDLE TO RETRACT, THE NEEDLE DID NOT RETRACT. THIS COULD HAVE CAUSED HARM TO THE CAREGIVER, NURSE, IF THEY HAD NOT REALIZED OR NOTICED THAT THE NEEDLE DID NOT RETRACT AS EXPECTED. EVENT DATE: 4/13/2026". ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58284 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120110 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1