BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 22419498 · Received July 7, 2025

    Report

    Report Number
    9617032-2025-01192
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 11, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643900
    PMA / PMN Number
    K202446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1: INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A TOTAL OF 10 RETAINED SAMPLES FROM EACH OF THE REPORTED LOT NUMBERS WERE INVESTIGATED, AND NO DEFECTS WERE IDENTIFIED IN MOLDING, SUB-ASSEMBLY, OR FUNCTIONALITY. ALL SYRINGES FUNCTIONED AS EXPECTED DURING THE FUNCTIONAL TESTS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR LOT 4060532, FOR THE INDICATED FAILURE MODE: INSUFFICIENT BLOOD FLOW. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿, THERE IS INSUFFICIENT BLOOD FLOW REQUIRING A MANUAL DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿, THERE IS INSUFFICIENT BLOOD FLOW REQUIRING A MANUAL DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177070 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4060532 50382903643900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown