BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24942350 · Received April 21, 2026

    Report

    Report Number
    1710034-2026-00441
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    January 14, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654 B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A DAMAGED CATHETER COULD NOT BE CONFIRMED FROM THE SHIELDED NEEDLE AND PHOTOGRAPH THAT WERE PROVIDED FOR INVESTIGATION. THE IV CATHETER WAS NOT RETURNED FOR INVESTIGATION. NO EVIDENCE WAS OBSERVED ON THE RETURNED SAMPLE THAT WOULD INDICATE THAT THE IV CATHETER WAS DAMAGED. ALTHOUGH THE MANUFACTURING RECORDS AND RETURNED PHOTO AND SAMPLE 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. 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

    PER CUSTOMER RESPONSE ON (B)(6) 2026 CLARIFICATION RECEIVED FOR MATERIAL 382544, LOT 5219644 TO BE INVESTIGATED FOR CATHETER TIP INTEGRITY AS THEY STATED "CATHETER TIP LOOKS MIS-SHAPED".

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221319 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5219644 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown