BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 23077038 · Received September 17, 2025

    Report

    Report Number
    1917413-2025-01317
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679332
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 23-SEP--2025. INVESTIGATION SUMMARY: BD RECEIVED TWO SAMPLES AND THREE PHOTOS FOR INVESTIGATION. THE EVALUATION OF BOTH REVEALED THE PRESENCE OF BROWN FOREIGN MATERIAL UNDER THE TUBE LABEL AND A DENT IN THE SIDE OF THE TUBE WALL. 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 BEEN CONFIRMED FOR THE LOT 4050352, FOR THE INDICATED FAILURE MODE: FOREIGN MATTER - OTHER. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4353204, FOR THE INDICATED FAILURE MODE: MANUFACTURING HEAT SOURCE. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD E1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES, 2 TUBES CONTAINED FOREIGN MATTER. THREE TUBES WERE ALSO REPORTED TO HAVE COLLAPSED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES, 2 TUBES CONTAINED FOREIGN MATTER. THREE TUBES WERE ALSO REPORTED TO HAVE COLLAPSED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705471 BD VACUTAINER® NAF 3.0MG N2E 6.0MG PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4050352 30382903679332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown