BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20740964 · Received November 20, 2024

    Report

    Report Number
    1710034-2024-01369
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 4, 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: THE COMPLAINT THAT THE NEEDLE DOES NOT RETRACT PROPERLY COULD NOT BE CONFIRMED FROM THE SAMPLES THAT WERE PROVIDED FOR INVESTIGATION. FOURTEEN INSYTE AUTOGUARD NEEDLES WERE RECEIVED FULLY RETRACTED WITHIN THE SHIELD. THE TOP WEB LABELS FROM LOT #4222721 WERE RECEIVED WITH THE RETRACTED NEEDLES. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES WOULD FULLY RETRACT WITHIN THE SHIELD. DUE TO SIMILAR COMPLAINTS THAT WERE CONFIRMED FOR THE IMPLICATED LOT, IT IS POSSIBLE THAT THE NEEDLES RETRACTED SLOWLY; HOWEVER, ONCE THE NEEDLE FULLY RETRACTS, THE REPORTED ISSUE MAY NOT BE POSSIBLE TO REPLICATE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908106 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