BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20544397 · Received October 28, 2024

    Report

    Report Number
    1710034-2024-01215
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 2, 2024
    Report Date
    January 27, 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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO 20GX1.00IN INSYTE AUTOGUARD DEVICES FROM LOT NUMBER 4190481. A GROSS VISUAL INSPECTION OF THE RETUNED UNIT SHOWS THAT THE UNIT HAS BEEN USED AND THE NEEDLES ARE RETRACTED IN THEIR BARRELS. THE RETURNED COMPONENTS DID NOT HAVE ANY APPARENT PHYSICAL DAMAGES. THE NEEDLES WERE RECEIVED FULLY RETRACTED AND ATTEMPTS TO REPLICATE THE REPORTED ISSUE SHOWED THAT THE NEEDLE RETRACTED WITHIN SPECIFICATION. WE WERE UNABLE TO CONFIRM YOUR REPORTED ISSUE. 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 AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    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 WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS RETRACTING SLOWING WHEN THE SAFETY BUTTON IS PRESSED. 7 OCT 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WHEN PRESSING THE WHITE BUTTON TO RETRACT THE NEEDLE, THERE IS A DELAY OR SOMETIMES NO RETRACTION OF THE NEEDLE AT ALL. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? OBSERVED DURING USE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE. PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURIES. 4. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 04-010-2024. 5. WAS BUTTON DEPRESSED? CAN THE BUTTON BE PUSHED OR DOES IT APPEAR ¿STIFF OR STUCK¿ THE BUTTON APPEARED TO BE STUCK. 6. DID NEEDLE RETRACT AT ALL? WAS THERE A NEEDLE STICK INJURY? NO INJURIES. THERE WERE A FEW INSTANCES WHERE THE NEEDLE DID NOT RETRACT AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167788 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4190481 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown