BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 22751553 · Received August 8, 2025

    Report

    Report Number
    1710034-2025-01309
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826124
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT THERE IS NO FAILURE ASSOCIATED WITH THIS DEVICE. THIS COMPLAINT WILL BE CANCELLED. CORRECTION: CANCEL MDR.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382612 AND LOT NUMBER 5043088. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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

    2 SEPTEMBER 2025 CUSTOMER ADDITIONAL INFORMATION RECEIVED: I HAD INITIALLY REPORTED BOTH MATERIALS REF # 382612 LOT # 504088 AND REF # 381412 LOT # 5058302 AND WAS LATER TOLD BY STAFF THAT NO ISSUES WERE FOUND WITH MATERIAL 382612 LOT 504088, THEY WERE PULLED AS A PRECAUTION.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER SPLITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: SPLITTING WHEN THEY TRY TO INSERT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224010 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5043088 00382903826124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown