BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24713028 · Received March 30, 2026

    Report

    Report Number
    1710034-2026-00330
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 16, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT 5133217 REGARDING ITEM #381023. DHR FOR FINAL LOT NUMBER 5133217 HAS BEEN REVIEWED. NO QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. A REVIEW OF THE APPLICABLE RISK DOCUMENTS 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 THE NURSE WAS ACCIDENTALLY PRICKED BECAUSE THE NEEDLE DID NOT FULLY RETRACT. ONCE THE DEVICE (NEEDLE CANNULA) WAS POSITIONED AND THE BUTTON TO RETRACT THE NEEDLE WAS PRESSED, THE NURSE WAS ACCIDENTALLY PRICKED BECAUSE THE NEEDLE DID NOT FULLY RETRACT AND ABOUT 1 CM OF THE TIP REMAINED EXPOSED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607148 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5133217 00382903810239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown