BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 23796555 · Received December 12, 2025

    Report

    Report Number
    1917413-2025-01659
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 17, 2025
    Report Date
    February 27, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903664307
    PMA / PMN Number
    K960250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: G.4. PMA / 510(K)#: K960250. H.1. IMDRF ANNEX A GRID (1): A0908 - INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FIBRIN. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    IT WAS REPORTED THAT CUSTOMER ALLEGES EXPERIENCING PERFORMANCE ISSUES WITH SERUM WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE CUSTOMER IS INQUIRING WHETHER SILICONE TUBES WOULD GENERATE MORE OR FEWER AGGREGATES IN THE SERUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER ALLEGES EXPERIENCING PERFORMANCE ISSUES WITH SERUM WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE CUSTOMER IS INQUIRING WHETHER SILICONE TUBES WOULD GENERATE MORE OR FEWER AGGREGATES IN THE SERUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484799 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) UNKNOWN 30382903664307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown