BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 24048622 · Received January 12, 2026

    Report

    Report Number
    1024879-2025-02415
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 15, 2025
    Report Date
    March 19, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN D4. MEDICAL DEVICE LOT #: UNKNOWN LOT NUMBER WAS NOT REPORTED; HOWEVER, 2 POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THESE LOT NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 5219436 D4. UNIQUE IDENTIFIER (UDI) #: ((B)(4) D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026 H4. DEVICE MANUFACTURE DATE: 07-AUG-2025 NOTE: DATE SHOULD USE DD-MMM-YYYY FORMAT. D4. MEDICAL DEVICE LOT #: 5239984 D4. UNIQUE IDENTIFIER (UDI) #:(B)(4) D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026 H4. DEVICE MANUFACTURE DATE: 27-AUG-2025 NOTE: DATE SHOULD USE DD-MMM-YYYY FORMAT. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. 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 DID NOT RECEIVE ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A SPECIFIC LOT NUMBER WAS NOT PROVIDED; HOWEVER 2 POTENTIAL LOT NUMBERS WERE PROVIDED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE POTENTIAL LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCTS. COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS FOR ERRONEOUS POTASSIUM RESULTS ON THE POTENTIAL LOTS. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: ERRONEOUS RESULTS . 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 1 PATIENT SAMPLE EXHIBITED ERRONEOUS HIGH POTASSIUM RESULTS. A GREEN TOP TUBE FROM THE SAME PATIENT EXHIBITED NORMAL RESULTS. THE SAMPLES WERE RETESTED AT ANOTHER LAB. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, 1 PATIENT SAMPLE EXHIBITED ERRONEOUS HIGH POTASSIUM RESULTS. A GREEN TOP TUBE FROM THE SAME PATIENT EXHIBITED NORMAL RESULTS. THE SAMPLES WERE RETESTED AT ANOTHER LAB. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107496 BD VACUTAINER® SST¿ TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON & CO (FRANKLIN LAKES) UNKNOWN 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown