BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19531989 · Received June 13, 2024

    Report

    Report Number
    1024879-2024-00527
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 30 RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO GEL BUBBLES BEFORE USE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE GEL BUBBLES BEFORE USE. 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

    MULTIPLE LOTS: D4. MEDICAL DEVICE LOT #: 3300804. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 27-OCT-2023. D4. MEDICAL DEVICE LOT #: 3257991. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 27-OCT-2023. D4. MEDICAL DEVICE LOT #: 3206578. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 27-OCT-2023. D4. MEDICAL DEVICE LOT #: 3201199. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 27-OCT-2023. G5. MULTIPLE 510(K): BK050036, K230855. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 700 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE AIR BUBBLES IN THE GEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 700 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE AIR BUBBLES IN THE GEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864443 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H11 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown