BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 22513054 · Received July 15, 2025

    Report

    Report Number
    1024879-2025-00986
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 19, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. THE LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 5142755. D4. MEDICAL DEVICE EXPIRATION DATE: 30-04-2026. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 22-05-2025. D4. MEDICAL DEVICE LOT#: 5118797. D4. MEDICAL DEVICE EXPIRATION DATE: 30-04-2026. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 28-04-2025. 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 ONE PHOTO FOR INVESTIGATION. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER PHOTO, THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS NOT OBSERVED. 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: STOPPER POP OFF. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, STOPPER POP OFF WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES RESULTING IN SAMPLE LEAKAGE ACROSS TWO POTENTIAL LOT NUMBERS. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, STOPPER POP OFF WAS SEEN WITH AN UNSPECIFIED NUMBER OF TUBES RESULTING IN SAMPLE LEAKAGE ACROSS TWO POTENTIAL LOT NUMBERS. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160185 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) UNKNOWN 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown