BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15521094 · Received September 30, 2022

    Report

    Report Number
    9617032-2022-00973
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 26, 2022
    Report Date
    February 14, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-18. H.6. INVESTIGATION SUMMARY: BD RECEIVED 12 SAMPLES FOR LOT 2164898 AND 30 SAMPLES FOR LOT 2164897 INVESTIGATION. NO PHOTOS WERE PROVIDED. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND REVEALED A CONFIRMED COMPLAINT TREND FOR CERTAIN SAMPLE QUALITY ISSUES. BASED ON THE CONFIRMED COMPLAINT TREND A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS INITIATED. 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 FIBRIN BASED ON THE TREND IDENTIFIED. A CORRECTIVE AND PREVENTIVE ACTION WAS CREATED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2164897, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2022-06-13. MEDICAL DEVICE LOT #: 2164898, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2022-06-13. MEDICAL DEVICE LOT #: 2145299, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2022-05-25. MEDICAL DEVICE LOT #: 2123430, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2022-05-03. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER IS EXPERIENCING PROBLEMS WITH FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿FOR SOME DAYS NOW WE HAVE BEEN EXPERIENCING PROBLEMS WITH FIBRIN CLOTS IN THE TUBES MENTIONED IN THE SUBJECT LINE AFTER CENTRIFUGATION ABOVE THE GEL SEPARATOR. THIS POSES A PROBLEM FOR OUR AUTOMATS. THE SAMPLING CONDITIONS (TURNING THE TUBES UPSIDE DOWN), THE TIME BEFORE CENTRIFUGATION (30 MINUTES) AND THE CENTRIFUGATION TIMES ARE WELL RESPECTED.¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER IS EXPERIENCING PROBLEMS WITH FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿FOR SOME DAYS NOW WE HAVE BEEN EXPERIENCING PROBLEMS WITH FIBRIN CLOTS IN THE TUBES MENTIONED IN THE SUBJECT LINE AFTER CENTRIFUGATION ABOVE THE GEL SEPARATOR. THIS POSES A PROBLEM FOR OUR AUTOMATS. THE SAMPLING CONDITIONS (TURNING THE TUBES UPSIDE DOWN), THE TIME BEFORE CENTRIFUGATION (30 MINUTES) AND THE CENTRIFUGATION TIMES ARE WELL RESPECTED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315676 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 2123430 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown