BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20814931 · Received December 1, 2024

    Report

    Report Number
    1710034-2024-01405
    Event Type
    Malfunction
    Date Received
    December 1, 2024
    Date of Event
    November 8, 2024
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381423 AND LOT NUMBER 4229661. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY NURSES SAID THAT THE IV CATHETERS OF THIS PARTICULAR LOT ARE MALFUNCTIONING. THE SAFETY FEATURE IS NOT WORKING CORRECTLY. NEEDLE FOR IV IS NOT RETRACTING. INJURIES OR ADVERSE EVENT: NO. 14 NOV: ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. 11-08-2024. 15 NOV: ITS NOT 1 DAY THAT IT HAPPENED IT IS THE ENTIRE BOX OF CATHETERS WE CAN'T REALLY RETAIN THEM DUE TO THE FACT THAT THEY HAVE BLOOD IN AND ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613973 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4229661 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown