BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRN ADAPTER

    MDR report key: 23416417 · Received October 29, 2025

    Report

    Report Number
    3006948883-2025-00817
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 18, 2025
    Report Date
    January 2, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4171423. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. 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

    ON (B)(6) 2025, DURING INTRAVENOUS INFUSION ADMINISTRATION TO THIS PATIENT, A CRACK WAS DISCOVERED AT THE KNOB OF A SINGLE-USE HEPARIN CAP. UPON DISCOVERY, THE CAP WAS IMMEDIATELY REPLACED WITH A NEW SINGLE-USE HEPARIN CAP AND REPORTED TO THE HOSPITAL'S ADVERSE EVENT SYSTEM. NO HARM WAS CAUSED TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720166 PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 4171423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown