BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC GLOBAL

    MDR report key: 23375709 · Received October 23, 2025

    Report

    Report Number
    1710034-2025-01649
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 2, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT A CONNECTION COULD NOT BE MADE WAS CONFIRMED BASED ON THE CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED ON THE BLUE CATHETER ADAPTER. FIVE PHOTOGRAPHS AND TWO 22GA INSYTE AUTOGUARD IV CATHETERS FROM LOT: 5120123 WERE PROVIDED FOR INVESTIGATION. THE INSIDE EDGE OF ONE BLUE CATHETER ADAPTER EXHIBITED DEFORMATION AT THE THREADED END. THE DAMAGE APPEARED TO BE MANUFACTURING RELATED. A FUNCTIONAL TEST CONFIRMED THAT A CONNECTION COULD BE MADE; HOWEVER, FLUID LEAKED FROM THE DAMAGED CATHETER ADAPTER. 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.

    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.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    THIS IS A COMPLAINT ABOUT HUB MALFUNCTION (UNABLE TO CONNECT) DURING USE. ACCORDING TO THE CUSTOMER REPORT COULD NOT INSERT SYRINGE OR EXTENSION TUBE TIP INTO CATHETER HUB (NARROW OR DEFORMED OPENING?) DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243393 INSYTE AUTOG BC GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5120123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown