BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 22047468 · Received May 19, 2025

    Report

    Report Number
    1710034-2025-00871
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    August 5, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826346
    PMA / PMN Number
    K201075
    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

    B3: THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3: A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MATERIAL INFORMATION AND ANNEX CODES UPDATED. INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. YOUR REPORT OF SLOW NEEDLE RETRACTION COULD NOT BE CONFIRMED FROM THE RETURNED SAMPLE. ONE INSYTE AUTOGUARD NEEDLE FROM LOT NUMBER 4150600 WAS PROVIDED FOR INVESTIGATION. THE NEEDLE WAS RECEIVED FULLY RETRACTED. A FUNCTIONAL TEST SHOWED THAT THE NEEDLE RETRACTED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE MAY PREVENT CONFIRMATION OF THE REPORTED ISSUE. ONCE THE NEEDLE FULLY RETRACTS, THE REPORTED ISSUE MAY NOT BE POSSIBLE TO REPLICATE. 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 OF RETRACTION ISSUES AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT LEADING TO BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE SLUGGISH WHEN RETRACTING DURING SAFETY ALLOWING BLOOD TO LEAK FROM HUB.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049750 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4150600 00382903826346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown