BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21667632 · Received March 21, 2025

    Report

    Report Number
    1710034-2025-00449
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 4, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT THAT THE BUTTON WAS STICKING ON THE SAFETY MECHANISM COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20GA INSYTE AUTOGUARD BC UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT NUMBER 4141830. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES FULLY RETRACTED AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. NO DAMAGE OR DEFECTS WERE OBSERVED ON THE RETURNED SAMPLES. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE STUCK; DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC XXXX ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. CUSTOMER REPORTED A BOX OF IV CATHETERS THE BUTTON WAS STICKING ONCE INSERTED AND THE NURSES WERE UNABLE TO REMOVE THE NEEDLE, CAUSING THEM TO STICK PATIENTS MORE THAN ONCE WHEN THEY HAD STARTED A GOOD IV. THE LOT NUMBER OF THIS BOX IS 4141830. CUSTOMER ADVISED HAVE USED THESE CATHETERS FOR SEVERAL YEARS AND THIS IS THE FIRST TIME THAT WE HAVE HAD THIS ISSUE. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT FEBRUARY 2025 ¿ MY STAFF COMPLAINED FOR SEVERAL DAYS THAT THE IV CATHETERS WERE STICKING. THEY WERE ALL FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213510 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4141830 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown