BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE YEL 24GA X 0.75IN

    MDR report key: 23570771 · Received November 17, 2025

    Report

    Report Number
    2243072-2025-01402
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903812127
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    DATE OF OCCURRENCE: (B)(6) 2025. DM REFERENCE: (B)(4). LOT NO.: 5023653. AFTER SUCCESSFULLY INSERTING THE BD INSYTE 24 GA CATHETER, IT IS IMPOSSIBLE TO CONNECT AN EXTENSION TUBE OR VALVE TO THE HUB. THE CATHETER IS REMOVED; THE HUB IS FOUND TO BE DEFORMED. CLINICAL CONSEQUENCES: ANOTHER CATHETER WAS INSERTED INTO THE PATIENT'S OTHER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859279 INSYTE YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5023653 00382903812127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown