BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20741066 · Received November 20, 2024

    Report

    Report Number
    1710034-2024-01373
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 7, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. HOWEVER, THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE IS CONFIRMED SINCE A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE MODE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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 WING NEEDLE DID NOT RETRACT PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DOES NOT RETRACT PROPERLY. NURSES HAVE REPORTED THAT IT IS DIFFICULT TO PUSH THE SAFETY BUTTON (THAT RETRACTS) THE NEEDLE. THERE HAVE BEEN 4 NEAR MISSES WITH A SHARP INJURY. I DID REPORT THIS TO OUR PERIOP HUDDLE AT 0915. THE LOT NUMBER ON ALL OF THESE OCCURRENCES (9) SO FAR TODAY IS THE SAME: 4222721. 6 NOV THERE WAS NO ACTUAL HARM OR INJURY BUT MULTIPLE NEAR MISS EVENTS DUE TO THE MECHANISM NOT FUNCTIONING PROPERLY. STAFF NURSES AND ANESHESIA PROVIDERS HAD TO MANUALLY DISENGAGE THE NEEDLE WHICH COULD HAVE CAUSED NEEDLE STICK INJURIES. YES, ALL DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427889 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown