BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15581763 · Received October 11, 2022

    Report

    Report Number
    9617032-2022-01007
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903679553
    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

    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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED, AND RED CELL HANG UP WAS OBSERVED. NO RED CELL RING WAS OBSERVED. INCORRECT ADDITIVE QUANTITY CANNOT BE CONFIRMED FROM PHOTOS. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND REVEALED A CONFIRMED COMPLAINT TREND FOR CERTAIN SAMPLE QUALITY ISSUES FOR LOT #¿S 2164897 AND 2171047. BASED ON THE CONFIRMED COMPLAINT TREND A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS INITIATED. THE COMPLAINT HISTORY REVIEW REVEALED NO OTHER COMPLAINTS IDENTIFIED FOR THE REPORTED ISSUES ON LOT # 2123429; NO TREND WAS FOUND ON THIS LOT NUMBER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT #'S, 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 RED CELL HANG UP BASED ON THE TREND IDENTIFIED AND THE PHOTOS PROVIDED. A CORRECTIVE AND PREVENTIVE ACTION WAS CREATED TO ADDRESS THE ISSUE ON LOT #¿S 2164897 AND 2171047. A ROOT CAUSE FOR LOT # 2123429 WAS UNABLE TO BE DETERMINED AND IS NOT INCLUDED IN THE CORRECTIVE AND PREVENTIVE ACTIONS. RED CELL RING WAS UNABLE TO BE CONFIRMED FROM THE PHOTOS PROVIDED. CLINICAL TESTING CONFIRMED RED CELL RING ON LOT # 2171047. INCORRECT ADDITIVE QUANTITY COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED UPDATING THE FOLLOWING FIELDS. B.5. EVENT DESCRIPTION: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INSUFFICIENT. ADDITIVE QUANTITY, AND RED CELL RING. THIS EVENT OCCURRED 30 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE'S NOT THE RIGHT QUANTITY OF CYCLONE IN THE TUBES. D.4. MEDICAL DEVICE LOT #. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2164897. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. H.4. DEVICE MANUFACTURE DATE: 2022-06-13. D.4. MEDICAL DEVICE LOT #: 2171047. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. H.4. DEVICE MANUFACTURE DATE: 2022-06-13. D.4. MEDICAL DEVICE LOT #: 2123429. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. H.4. DEVICE MANUFACTURE DATE: 2022-06-13.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INSUFFICIENT ADDITIVE QUANTITY. THIS EVENT OCCURRED 30 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE'S NOT THE RIGHT QUANTITY OF CYCLONE IN THE TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INSUFFICIENT ADDITIVE QUANTITY, AND RED CELL RING. THIS EVENT OCCURRED 30 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE'S NOT THE RIGHT QUANTITY OF CYCLONE IN THE TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED INSUFFICIENT. ADDITIVE QUANTITY, AND RED CELL RING. THIS EVENT OCCURRED 30 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE'S NOT THE RIGHT QUANTITY OF CYCLONE IN THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341572 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10. 00382903679553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown