BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM TUBE

    MDR report key: 24192744 · Received January 27, 2026

    Report

    Report Number
    1024879-2026-00049
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 31, 2025
    Report Date
    February 18, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: REPORT 1 OF 2: IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SERUM TUBES, THE CAP COULD NOT BE REMOVED FROM FOUR (4) TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. E.1. INITIAL REPORTER PHONE # (B)(6). INVESTIGATION SUMMARY: BD RECEIVED 7 PHOTOS FOR INVESTIGATION, WHICH SHOW MULTIPLE SAMPLES WITH SHIELDS SEPARATED FROM THE STOPPERS. 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 LOTS 5042703 AND 5042705, FOR THE INDICATED FAILURE MODE: CLOSURE SEPARATION. 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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® SERUM TUBE, THE CAP COULD NOT BE REMOVED. 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® SERUM TUBE, THE CAP COULD NOT BE REMOVED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603133 BD VACUTAINER® SERUM TUBE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) 5042703 30382903678120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown