BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 22084928 · Received May 26, 2025

    Report

    Report Number
    1710034-2025-00901
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. THE REPORT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOTS 4341713, 4305281, AND 4141827. A FUNCTIONAL TEST SHOWED THAT EACH NEEDLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED, AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE OF RETRACTION ISSUES AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. COMPLAINTS RECEIVED FOR 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 COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT WHILE USING ITEM 382534, AND THEY HIT THE BUTTON, IT DOES NOT RETURN. THEY HAVE TESTED 5 OUT OF EACH LOT AND THEY ARE ALL DOING THE SAME THING. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO, HAD TO RESTICK PATIENT BUT NO GREATER ADVERSE EVENT. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 14/05/2025. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? DID NOT RETRACT AT ALL. DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED? NO. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? YES, IT DID NOT MOVE. DID THE BUTTON DEPRESS? PARTIALLY, GOT STUCK PART OF THE WAY INTO DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331984 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4305281 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown