BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 12510846 · Received September 21, 2021

    Report

    Report Number
    1024879-2021-00646
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 26, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1116417, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2021-04-26. MEDICAL DEVICE LOT #: 1116416, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2021-04-26. MEDICAL DEVICE LOT #: 1109478, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2021-04-19. MEDICAL DEVICE LOT #: 1137504, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2021-05-17. MEDICAL DEVICE LOT #: 1137500, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2021-05-17. INVESTIGATION SUMMARY: "MATERIAL #: 367986. LOT/BATCH #: 1116417, 1116416, 1109478, 1137504, & 1137500. BD RECEIVED THIRTEEN (13) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES 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 OF GEL AIR BUBBLES. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO INADEQUATE PURGING DURING GEL DRUM CHANGES. A TOOL WAS IMPLEMENTED AT THE GEL DISPENSE AREA TO HELP AID IN IDENTIFYING AND ELIMINATING GEL DEFECTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED, - "I HAVE ADDITIONAL LOT #S WITH THE SAME ISSUE: IT IS REPORTED CUSTOMER WITNESSED GEL AIR BUBBLES IN GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404164 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10. 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1