BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 23005717 · Received September 9, 2025

    Report

    Report Number
    1024879-2025-01242
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 14, 2025
    Report Date
    November 25, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. 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 RECEIVED FOUR PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND SHOWED THE TIP OF AN AUTOMATIC ANALYZER COVERED IN GEL RESIDUE. A VISUAL INSPECTION WAS PERFORMED ON 30 RETAINED SAMPLES FROM LOT NUMBER 5093427 FOR GEL DEFECTS, AND ALL SAMPLES PASSED. SIMILARLY, 30 RETAINED SAMPLES FROM LOT NUMBER 5105263 WERE VISUALLY INSPECTED FOR GEL DEFECTS, AND ALL SAMPLES PASSED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 5093427, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THE DEVICE HISTORY RECORD FOR LOT 5105263 REVEALED A QUALITY NOTIFICATION FOR GEL AIRBUBBLES WAS GENERATED. HOWEVER, ALL LOTS PASSED ALL IN-PROCESS AND FINAL QUALITY CHECKS FOR LOT RELEASE. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOTS 5093427 AND 5105263, FOR THE INDICATED FAILURE MODE: OIL GEL GLOBULES. BASED ON A REVIEW OF BATCH RECORDS, THE GEL AIRBUBBLES FOUND IN LOT 5105263 WAS IDENTIFIED AS A CONTRIBUTOR TO THE CUSTOMER REPORTED DEFECTS. 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.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, OIL GEL GLOBULES WERE SEEN INSIDE AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, OIL GEL GLOBULES WERE SEEN INSIDE AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2803039 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5105263 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown