BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA

    MDR report key: 23509458 · Received November 10, 2025

    Report

    Report Number
    9610847-2025-00408
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    CORRECTION: (E) FDA NOTIFIED? YES. ADDITIONAL INFORMATION: (H) ATTACHED MEDSUN AND ADDED REPORT NUMBER. INVESTIGATION RESULTS: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5021746. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IV STARTED, SAFETY MECHANISM ATTEMPTED TO ENGAGE. SAFETY DID NOT ENGAGE, NEEDLE EXPOSED. NEEDLE DISPOSED IN SHARPS CONTAINER. NO INJURY OCCURRED TO STAFF OR PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616042 SAF-T-INTIMA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5021746 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown