BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 20879513 · Received December 9, 2024

    Report

    Report Number
    1024879-2024-01206
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    October 28, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903673002
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: 11-DEC-2024. D4. MEDICAL DEVICE LOT #: 4171475. D.4 MEDICAL DEVICE CATALOG #367300. INVESTIGATION SUMMARY: BD RECEIVED 33 SAMPLES FOR INVESTIGATION RELATED TO LOT 4171475. OUT OF THESE, TEN RETURNED SAMPLES UNDERWENT FUNCTIONAL TESTS USING 30 TUBES PER NEEDLE, AND ALL PASSED WITHOUT ANY ISSUES SUCH AS SLEEVE FALL OFF, SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR SLEEVE LEAKAGE. ADDITIONALLY, TEN RETAINED SAMPLES FROM THE SAME LOT WERE TESTED IN THE SAME MANNER AND ALSO PASSED ALL TESTS. FOR LOT 3153005, TEN RETAINED SAMPLES UNDERWENT FUNCTIONAL TESTS AND PASSED WITHOUT ANY DEFECTS. SIMILARLY, FOR LOT 4095793, TEN RETAINED SAMPLES WERE TESTED AND ALL MET THE REQUIRED STANDARDS WITHOUT ANY DEFECTS. 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 THE LOTS 3153005, 4095793 AND 4171475, FOR THE INDICATED FAILURE MODE: SLEEVE FALL OFF. 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

    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

    INCIDENT 1 OF 4: IT WAS REPORTED WHEN USING ONE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE RUBBER SLEEVE COVERING THE NEEDLE FELL OFF RESULTING IN SAMPLE LEAKAGE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    INCIDENT 1 OF 4: IT WAS REPORTED WHEN USING ONE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE RUBBER SLEEVE COVERING THE NEEDLE FELL OFF RESULTING IN SAMPLE LEAKAGE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333627 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4171475 30382903673002

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown