BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21425360 · Received February 20, 2025

    Report

    Report Number
    1710034-2025-00286
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 27, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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 SLOW 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 IDENTIFY THE ROOT CAUSE.

    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 NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SLOW RETRACTION OF NEEDLE INTO SAFETY HOUSING. ON (B)(6) 2025 CUSTOMER RESPONSE: 1. NO IMPACT TO PATIENT BUT IS RISKY SITUATION. 2. YES, AFTER IV START, DELAY IN NEEDLE RETRACTION, NO INJURY BUT RISKY SITUATION. 3. NO INJURY TO STAFF OR PT. 4. 1/27/2025 5. LOT # IS WHAT WAS PROVIDED, NO OTHER INFO AVAILABLE. 6. NO PHOTO. 7. SEVERAL SEPARATE INCIDENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037318 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female