BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 20373159 · Received October 4, 2024

    Report

    Report Number
    1024879-2024-00904
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 9, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. INVESTIGATION SUMMARY: MATERIAL #: 367986; LOT/BATCH #: 4152613. BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR EMBEDDED FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE EMBEDDED FOREIGN MATTER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD VACUTAINER® SST¿ THERE WAS FOREIGN MATTER INSIDE ONE TUBE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712550 BD VACUTAINER® SST¿ EVACUATED BLOOD COLLECTION TUBE IVD, CLOT ACTIVATOR/SEPARATOR JKA BECTON, DICKINSON & CO., (BD) 4152613 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown