BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM

    MDR report key: 23687641 · Received December 1, 2025

    Report

    Report Number
    1024879-2025-01917
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903678120
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    INVESTIGATION SUMMARY. BD RECEIVED SEVEN PHOTOS FOR INVESTIGATION, WHICH SHOWED MULTIPLE SAMPLES WITH THEIR STOPPERS STUCK IN THEM, AND THE STOPPERS HAD BEEN SEPARATED FROM THEIR SHIELDS. 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 5042703, FOR THE INDICATED FAILURE MODE: CLOSURE SEPARATION. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A 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

    REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE CAP OF TWO TUBES FAILED TO SEPARATE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THE CAP OF TWO TUBES FAILED TO SEPARATE WHILE ON THE ANALYZER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739045 BD VACUTAINER® SERUM TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5042703 30382903678120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown