BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24757473 · Received April 1, 2026

    Report

    Report Number
    1710034-2026-00361
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT THE NEEDLE DID NOT RETRACT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE INSYTE AUTOGUARD NEEDLE FROM LOT 5265765 WAS PROVIDED FOR INVESTIGATION. MISPLACED ADHESIVE WAS IDENTIFIED ON THE DEVICE, WHICH PREVENTED THE NEEDLE FROM RETRACTING. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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.

    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.

    Description of Event or Problem · 0

    NO NEW INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. AS THE NURSE WAS COMPLETING PLACING AN IV THE SAFETY BUTTON TO RETRACT THE NEEDLE WAS PRESSED AND THE NEEDLE DID NOT RETRACT. THE NURSE WAS ABLE TO PULL OUT THE NEEDLE MANUALLY AND THERE WAS NO IMPACT TO THE PATIENT OR THE EMPLOYEE. THE IV WAS SUCCESSFULLY STARTED. CUSTOMER RESPONSE ON MAR-27: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 09 FEB 2026 WHAT WAS THE IMPACT TO THE PATIENT? THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542082 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5265765 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown