BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 23420420 · Received October 29, 2025

    Report

    Report Number
    1024879-2025-01679
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 30, 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

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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 5093427. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2026. H4. DEVICE MANUFACTURE DATE: 03-APR-2025. D.4 UDI#:(B)(4). D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 03-NOV-2025. INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO AND TWO SAMPLES FOR INVESTIGATION. THE PHOTO DEPICTS MULTIPLE TUBES WITHOUT LABELS. ADDITIONALLY, THE TWO RETURNED SAMPLES UNDERWENT A VISUAL INSPECTION FOR MISSING LABELS, AND BOTH SAMPLES FAILED THE INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED A QUALITY NOTIFICATION WAS RAISED FOR THIS ISSUE. HOWEVER, LOT PASSED ALL IN-PROCESS AND FINAL QUALITY CHECKS FOR LOT RELEASE. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: INCORRECT/MISSING LABEL INFORMATION. THE ROOT CAUSE WAS DETERMINED TO BE THE LABEL VISION SYSTEM'S CAMERA BEING OUT OF POSITION. THE CAMERA WAS FIXED AT TIME OF DISCOVERY. 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 PRIOR TO USING BD VACUTAINER® SST¿, THREE (3) TUBES WERE MISSING A LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SST¿, THREE (3) TUBES WERE MISSING A LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445557 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5093427 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown