BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24401054 · Received February 20, 2026

    Report

    Report Number
    1710034-2026-00167
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810123
    PMA / PMN Number
    K251654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. CHARACTERS LIMIT IS EXCEEDED AT FACILITY NAME: (B)(6) HOSPITAL. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF UNINTENDED MATERIAL IN THE PACKAGING WAS CONFIRMED. HOWEVER, THE SOURCE OF THE MATERIAL COULD NOT BE DETERMINED. FIVE PHOTOGRAPHS AND ONE 24G INSYTE AUTOGUARD IV CATHETER WERE PROVIDED FOR INVESTIGATION. ONE PHOTO SHOWED A CLEAR SUBSTANCE WITH DARK SPOTS ON THE EXTERNAL SURFACE OF THE CATHETER. THE MATERIAL WAS RECEIVED INSIDE A PLASTIC BAG. A MATERIAL ANALYSIS INDICATED A 73% MATCH TO A THERMOPLASTIC POLYMER. THE IV CATHETER WAS RECEIVED SEPARATE FROM THE MATERIAL. THE NEEDLE WAS NOT PROVIDED FOR INVESTIGATION AND WAS NOT SHOWN IN ANY OF THE PROVIDED PHOTOGRAPHS, WHICH INDICATES THAT THE DEVICE HAD BEEN REMOVED FROM ITS PACKAGING AND MANIPULATED BEFORE PHOTOGRAPHS WERE TAKEN AND BEFORE THE SAMPLE WAS PROVIDED FOR INVESTIGATION. TWO OPEN UNIT PACKAGES FROM LOTS 5191509 AND 5191576 WERE RETURNED WITH THE IV CATHETER. HOWEVER, IT COULD NOT BE DETERMINED WHICH LOT WAS ASSOCIATED WITH THE REPORTED EVENT. THERE WERE NO OTHER SIMILAR COMPLAINTS FROM EITHER LOT. A REVIEW OF THE INSPECTION RECORDS AND QUALITY AND MANUFACTURING CONTROLS FOR EACH LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. 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. COMPLAINTS RECEIVED ABOUT THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CUSTOMER OPENED THE CAP BEFORE USE, THERE WAS DUST ON THE TIP, END POINT OF THE CATHETER BEFORE USE.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391975 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown