BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 23051540 · Received September 15, 2025

    Report

    Report Number
    1024879-2025-01267
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 15, 2025
    Report Date
    February 24, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903672906
    PMA / PMN Number
    K243649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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: 22-SEP-2025. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K991088. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE FOR INVESTIGATION. THE 1 CUSTOMER SAMPLE WAS USED AND COULD NOT BE FUNCTIONALLY TESTED FOR INSUFFICIENT BLOOD FLOW. HOWEVER, THE CUSTOMER SAMPLE WAS SUBJECTED TO VISUAL INSPECTION FOR DAMAGED PRODUCT. THE SAMPLE FAILED TESTING AS THE DEVICE WAS DAMAGED. ADDITIONALLY, 10 RETAINED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTS, AND ALL SAMPLES PASSED, SHOWING NO SIGNS OF DAMAGE, LEAKAGE, OR INSUFFICIENT BLOOD FLOW DURING USE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR DAMAGED BASED ON THE RETURNED SAMPLE. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: INSUFFICIENT BLOOD FLOW. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. BASED ON THE LOW DEFECT RATE FOR THE BATCH IN QUESTION, NO ACTIONS ARE PLANNED AT THIS TIME. 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 VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE UNIT STOPPED DRAWING BLOOD INTO THE TUBES. 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 VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE UNIT STOPPED DRAWING BLOOD INTO THE TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519233 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 30382903672906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown