BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC

    MDR report key: 20423068 · Received October 10, 2024

    Report

    Report Number
    1710034-2024-01130
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    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 RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE ADAPTER CONNECTOR AND ONE CATHETER ADAPTER OF A 22GX1.00IN INSYTE AUTOGUARD DEVICE FROM LOT # 4123607. A GROSS VISUAL INSPECTION OF THE PHYSICAL UNIT SHOWS THAT THE COMPONENTS HAVE BEEN USED THOUGH NO PHYSICAL DAMAGE WAS IDENTIFIED. A FUNCTIONAL TEST SHOWED NO LEAKS BETWEEN THE INJECTION CAP AND THE CATHETER ADAPTER. NO LEAKS OR CONNECTION ISSUES COULD BE CONFIRMED FROM THE RETURNED SAMPLE. YOUR REPORTED ISSUE OF AN IMPROPER CONNECTION AND SUBSEQUENT LEAKAGE COULD NOT BE CONFIRMED FROM THE RETURNED SAMPLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC DID NOT CONNECT WELL AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER HUB WOULD NOT CONNECT ONTO J-LOOP CONNECTOR. I CHANGED TUBING AND STILL WOULD NOT CONNECT COMPLETELY AND LEAKED. I ENDED UP TAKING OFF THE TUBING AND JUST USING THE SMALL CONNECTOR PIECE ON THE END OF THE J-LOOP TUBING. THE HUB STILL LEAKED, BUT I WENT AHEAD AND INJECTED BECAUSE I DIDN'T WANT TO START A NEW IV ON THE PT. 25 SEP. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NONE. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335839 INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123607 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown