BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 13458805 · Received February 4, 2022

    Report

    Report Number
    9617032-2022-00068
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1293968. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2021-10-20. MEDICAL DEVICE LOT #: 1151161. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-05-31. MEDICAL DEVICE LOT #: 1271818. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2021-09-28. MEDICAL DEVICE LOT #: 1293967. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2021-10-20. MEDICAL DEVICE LOT #: 1245697. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2021-09-02 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1293968. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2021-10-20. MEDICAL DEVICE LOT #: 1151161. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-05-31. MEDICAL DEVICE LOT #: 1271818. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2021-09-28. MEDICAL DEVICE LOT #: 1293967. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2021-10-20. MEDICAL DEVICE LOT #: 1245697. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2021-09-02 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

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, 4 RETAINED SAMPLES FROM EACH BATCH NUMBER: 1293968, 1151161, 1271818, 1293967, 1245697 WERE DRAWN WITH HORSE BLOOD, MIXED, AND STOOD FOR 30 MINUTES. THEY WERE THEN CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL 20 SAMPLES SEPARATED AS EXPECTED. 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 POOR BARRIER SEPARATION BASED ON THE PHOTOS ONLY. RETENTION SAMPLE TESTING WAS SATISFACTORY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE, HOWEVER IT WAS NOTED BY THE CUSTOMER THAT THEY FOUND AN ISSUE WITH THE CENTRIFUGE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING CENTRIFUGE THE GEL DOES NOT SEPARATE THE RED BLOOD CELLS FROM THE SERUM, IT REMAINS AT THE BOTTOM OR ON THE EDGES OF THE TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING CENTRIFUGE THE GEL DOES NOT SEPARATE THE RED BLOOD CELLS FROM THE SERUM, IT REMAINS AT THE BOTTOM OR ON THE EDGES OF THE TUBE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING CENTRIFUGE THE GEL DOES NOT SEPARATE THE RED BLOOD CELLS FROM THE SERUM, IT REMAINS AT THE BOTTOM OR ON THE EDGES OF THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421785 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367957 SEE H.10 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown