BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23872630 · Received December 22, 2025

    Report

    Report Number
    1710034-2025-01975
    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 NEW INFORMATION.

    Description of Event or Problem · 0

    TO INVESTIGATE FURTHER, SEVERAL UNOPENED UNITS FROM THE SAME LOT WERE TESTED. MULTIPLE CATHETERS DEMONSTRATED SLUGGISH OR FAILED NEEDLE RETRACTION, AND IN SOME CASES, THE SHEATH WAS FIRMLY ADHERED TO THE NEEDLE. NO PACKAGING DEFECTS WERE NOTED. IMMEDIATE ACTIONS TAKEN: ALL CATHETERS FROM THE AFFECTED LOT HAVE BEEN REMOVED FROM SERVICE AND QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715645 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5223795 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown