BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23872644 · Received December 22, 2025

    Report

    Report Number
    1710034-2025-01976
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 13, 2026
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381433 AND LOT NUMBER 5223795. A QUALITY NOTIFICATION RELATED TO THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE WAS INITIATED DURING THE BUILD OF THIS LOT, AND QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED FOR THE DEFECTS OF NEEDLE RETRACTION SLOW AND TIP ADHESION / BONDED TO NEEDLE. HOWEVER, WITHOUT A SAMPLE WE CANNOT CONFIRM THAT THIS FAILURE WAS RELATED TO THAT NOTIFICATION. BASED ON THE AVAILABLE INFORMATION, 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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    I AM REACHING OUT REGARDING A CONCERN IDENTIFIED WITH BD INSYTE¿ AUTOGUARD¿ IV CATHETERS IN OUR EMERGENCY DEPARTMENT. DURING IV INSERTION, A NURSE REPORTED THAT THE NEEDLE DID NOT RETRACT AFTER PRESSING THE SAFETY BUTTON. THE CATHETER SHEATH ALSO FAILED TO REMAIN SECURED, REQUIRING REMOVAL OF THE ENTIRE DEVICE. ADDITIONAL VENIPUNCTURE ATTEMPTS WERE NECESSARY TO ESTABLISH IV ACCESS. AFTER THE DEVICE WAS REMOVED, THE NEEDLE STILL DID NOT RETRACT DESPITE MULTIPLE ATTEMPTS. ANY INJURIES AND/OR HARM? MULTIPLE IV STARTS, NO HARM NOTED WHAT IS THE ISSUE YOU EXPERIENCED? UNABLE TO RETRACT NEEDLE USING SAFETY BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716579 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5223795 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown