BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 25001581 · Received April 27, 2026

    Report

    Report Number
    1710034-2026-00472
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. 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 NEEDLE RETRACTION FAILURE - NEEDLE RETRACTION SLOW WITH LOT 6020809 REGARDING ITEM 382533. DEVICE HISTORY FOR FINAL LOT NUMBER 6020809 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND FOR NEEDLE RETRACTION FAILURE OR NEEDLE RETRACTION SLOW 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

    IV NEEDLE SLOW TO RETRACT, ONLY FULLY RETRACTED ONCE REMOVED AFTER INSERTION. LOT #6020809 BD INSYTE AUTOGUARD BC. THE NEEDLE NOT RETRACTING POSES A SAFETY RISK TO THE USER. NO PATIENT HARM NOTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279094 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6020809 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female