BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 23000102 · Received September 9, 2025

    Report

    Report Number
    3003916417-2025-00180
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    UDI-DI
    30382903600596
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS OBSERVED. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY OF LOT 5151532 WERE EVALUATED BY VISUAL EXAMINATION AND 5 SAMPLES WERE FUNCTIONALLY TESTED AND THE ISSUE OF STOPPER POP OFF WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT 5151532, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS UNABLE TO DETERMINE THE UNKNOWN NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF STOPPERS CAME OFF DURING TRANSPORT AND LEAKED. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 1 OF 2: IT WAS REPORTED DURING USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF STOPPERS CAME OFF DURING TRANSPORT AND LEAKED. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258463 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON IND. CIRURGICAS LTDA 5151532 30382903600596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown