BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25016623 · Received April 28, 2026

    Report

    Report Number
    1710034-2026-00473
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810239
    PMA / PMN Number
    K251654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT 5073713 REGARDING ITEM 381023. DEVICE HISTORY WAS REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY LOT AND PACKAGING LINE. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTED ON THE CATHETER. CAP REMOVED TO CANULATE PT. SMALL FOREIGN BODY/DEBRIS NOTED ON TIP OF THE CANULAR. NEEDLE RETRACTED AND DEBRIS REMAIN STUCK TO THE CANNULA. DID NOT GO INTO PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618081 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5073713 00382903810239

    Patients

    Seq Age Sex Outcome Treatment
    1