BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 18003512 · Received October 25, 2023

    Report

    Report Number
    1710034-2023-01224
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 83 SEALED 22G X 1.00IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 3192272. THE UNITS WERE VISUALLY INSPECTED, AND NO DAMAGE/DEFECTS WERE IDENTIFIED TO THE COMPONENTS. A SAMPLING OF (B)(4)UNITS WERE FUNCTIONALLY TESTED FOR NEEDLE RETRACTION. ALL TESTED UNITS SUCCESSFULLY RETRACTED WITHOUT ISSUE. 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 THE REPORT. 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 DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT IS REPORTED THAT BD INSYTE AUTOG BC BLU 22GA X 1.0IN HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: NURSING HERE AT HAWKINS LET ME KNOW THEY HAD SOME TROUBLE WITH #176586 ¿ 22G CATHETER IV INSYTE BLUE RETRACTING PROPERLY (NO HARM TO THE PATIENT) LAST NIGHT AND AGAIN EARLIER THIS MORNING. THESE IV¿S CAME FROM THE SAME LOT#3192272. THEY PULLED THEIR STOCK OF THIS LOT ((B)(4)) AND IT IS NOW IN MY OFFICE. HANCOCK HAS 0 OF THIS LOT# AND 0 FOUND IN INVENTORY. NURSING AT HAWKINS DID ENTER THIS INTO RL SOLUTIONS WITH A POSSIBILITY OF IT BEING MENTIONED BY (B)(6) ON HER CALL AFTER OUR MORNING HUDDLE. PARS ARE STOCKED AND OUR CURRENT INVENTORY HAS A DIFFERENT LOT#. ADDITIONAL INFO FROM CUSTOMER: -CAN YOU CONFIRM THE QUANTITY OF DEFECTIVE PRODUCTS IS (B)(4) PIECES?: YES. -ARE YOU ABLE TO PROVIDE SAMPLE TO BD FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED?: WE CAN PROVIDE UNUSED SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048591 BD NSYTE AUTOG BC BLU 22GA X 1.0IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192272 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown