BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23421205 · Received October 30, 2025

    Report

    Report Number
    1710034-2025-01690
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 3, 2025
    Report Date
    January 23, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS CORRECTION (WRONG SUMMARY INITIALLY SUBMITTED): THE COMPLAINT THAT THE NEEDLE DID NOT FULLY RETRACT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FIVE 18G INSYTE AUTOGUARD BC DEVICES WERE PROVIDED FOR INVESTIGATION WITH OPEN UNIT PACKAGES FROM LOTS 5052302, 5120110, AND 5174502. IT COULD NOT BE DETERMINED WITH CERTAINTY WHICH LOT(S) THE UNITS WERE FROM. THE SAFETY MECHANISM HAD BEEN ACTIVATED ON EACH SAMPLE. TWO NEEDLES WERE RECEIVED FULLY RETRACTED. THREE NEEDLES WERE RECEIVED WITH THE FLASH NOTCH CAUGHT ON THE BLOOD CONTROL VALVE. AFTER MANIPULATING THE IV CATHETER, THE NEEDLE ENDED UP FULLY RETRACTING WITHIN THE SAFETY SHIELD. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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

    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 NEW INFORMATION.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    AFTER THE IV CATHETER WAS INSERTED, THE NEEDLE WAS STUCK AND DID NOT RETRACT. THE NURSE WAS ABLE TO LEAVE THE CATHETER IN THE SKIN AND PULL THE NEEDLE OUT. NEEDLE STILL DID NOT RETRACT WHEN TAKEN OUT OF THE PATIENT. I DON¿T THINK MY NURSES HAVE BEEN REPORTING EVERY INSTANCE SINCE THIS HAS BEEN ONGOING FOR OVER A MONTH NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618816 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5052302 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown