BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21326972 · Received February 6, 2025

    Report

    Report Number
    1710034-2025-00140
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    December 17, 2024
    Report Date
    March 19, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF RETRACTION ISSUE COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED UNIT PACKAGES FROM LOT #4212199. A FUNCTIONAL TEST OF THE RETURNED SAMPLES REVEALED NO RETRACTION DELAYS AND THE NEEDLES FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. THE AFFECTED UNITS WERE NOT RETURNED FOR INVESTIGATION. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTIFY THE ROOT CAUSE. ALTHOUGH THE REPRESENTATIVE SAMPLES 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.

    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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAS AN UNDEFINED NEEDLE RETRACTION PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVING ISSUES WITH SAFETY RETRACTING THE NEEDLE WHEN PLACING. RISK OF NSI

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909064 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212199 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown