BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17873155 · Received October 4, 2023

    Report

    Report Number
    9617032-2023-01305
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    November 21, 2022
    Report Date
    January 25, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION AS THE BATCH NUMBER IS 2203590. REPORT 7 OF 12: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WAS HEMOLYSIS AND POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT ID: (B)(6). WE HAVE HAD THREE SAMPLES WITHIN A DAY OF EACH OTHER, FROM ND GUM WHERE THE SAMPLES HAVE BEEN GROSSLY LYSED, SERUM GEL NOT SEPARATING PROPERLY AFTER CENTRIFUGATION. WE ACTUALLY HAVE HAD SEVERAL MORE OVER THE LAST MONTH. 5ML GOLD BD SSTS BATCH NUMBER IS 2203590 EXP 01/2024." H.6. INVESTIGATION SUMMARY: MATERIAL #: 367956. LOT/BATCH #: 2203590. BD RECEIVED THREE (3) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS AND POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, ADDITIVE ABNORMALITY AND GEL DEFECT WERE NOT OBSERVED THAT COULD LEAD TO THE INDICATED FAILURE MODE FOR HEMOLYSIS AND POOR BARRIER SEPARATION. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AS ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE, HEMOLYSIS AND POOR BARRIER SEPARATION, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 HEMOLYSIS AND POOR BARRIER SEPARATION BASED ON PHOTOS ONLY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    REPORT 7 OF 12: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WAS HEMOLYSIS AND POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT ID: (B)(6). WE HAVE HAD THREE SAMPLES WITHIN A DAY OF EACH OTHER, FROM ND GUM WHERE THE SAMPLES HAVE BEEN GROSSLY LYSED, SERUM GEL NOT SEPARATING PROPERLY AFTER CENTRIFUGATION. WE ACTUALLY HAVE HAD SEVERAL MORE OVER THE LAST MONTH. 5ML GOLD BD SSTS BATCH NUMBER IS 2189022 EXP 01/2024."

    Description of Event or Problem · 0

    REPORT 7 OF 12. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WAS HEMOLYSIS AND POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT ID: (B)(6). WE HAVE HAD THREE SAMPLES WITHIN A DAY OF EACH OTHER, FROM ND GUM WHERE THE SAMPLES HAVE BEEN GROSSLY LYSED, SERUM GEL NOT SEPARATING PROPERLY AFTER CENTRIFUGATION. WE ACTUALLY HAVE HAD SEVERAL MORE OVER THE LAST MONTH. 5ML GOLD BD SSTS BATCH NUMBER IS 2203590 EXP 01/2024."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466770 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2203590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown