BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24864287 · Received April 13, 2026

    Report

    Report Number
    1710034-2026-00405
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 WITH LOT 5210685 REGARDING ITEM 382523. DHR NUMBER 5210685 HAS BEEN 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 DOCUMENTS INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Additional Manufacturer Narrative · 0

    THIS MDR CAPTURES EVENT 3 OF 3 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. IV NEEDLE DID NOT RETRACK WHEN WHITE BUTTON PRESSED TO ENGAGED SAFETY. ADDITIONAL INFORMATION 3/23/2026: PER STAFF: NO PATIENT HARM. THESE WERE NEAR MISS EVENTS THAT HAD THE POTENTIAL TO CAUSE INJURY TO EMPLOYEES. 4/6/2026 ADDITIONAL INFORMATION: DIFFERENT PATIENTS, SAME HCP. NO FURTHER INCIDENTS HAVE BEEN REPORTED TO ME AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106310 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5210685 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown