BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 21269960 · Received January 29, 2025

    Report

    Report Number
    1710034-2025-00089
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 13, 2025
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 49 INSYTE AUTOGUARD BC 20GA 1.00 UNITS FROM MATERIAL NUMBER 382633, LOT NUMBER 4222721. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR FUNCTIONAL TESTING. YOUR REPORTED ISSUE OF A SLOW RETRACTION WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED DUE TO GEL MISPLACEMENT. 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 AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE RETRACTION IS SLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT WHEN USING ITEM 382633, LOT 4222721, THERE IS A DELAY WHEN PUSHING THE BUTTON AND THE NEEDLE DOES NOT RETRACT. DATE OF EVENT: 13JAN2025; OCCURRENCE NUMBER: 3. CUSTOMER DOES HAVE PRODUCT TO RETURN IF NEEDED. ADDRESS OF FACILITY: (B)(6) 2025 THE NEEDLES HAD A DELAYED RETRACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644124 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