BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 16811964 · Received April 25, 2023

    Report

    Report Number
    9617032-2023-00486
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 4, 2023
    Report Date
    July 20, 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
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION AND ADDITIVE ABNORMALITY WAS NOT OBSERVED (ERRONEOUS RESULTS CANNOT BE EVALUATED BY PHOTOS). ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED (NO ADDITIVE OR GEL DEFECTS WERE NOTED). CERTAIN ASSAYS, IN THIS CASE HIV TESTING, ARE EXCLUDED FROM BD CLINICAL PROTOCOLS. THEREFORE, WE ARE AT THE PRESENT TIME, UNABLE TO PERFORM INTERNAL TESTING FOR INFECTIOUS DISEASES. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 IS UNABLE TO BE CONFIRMED FOR POOR BARRIER SEPARATION, ADDITIVE ABNORMALITY, AND ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 THE SAMPLE, DISCOLORED/ABNORMAL ADDITIVE FORM AND ERRONEOUS RESULTS. THE ABNORMAL ADDITIVE ISSUES AFFECTED 6000 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE SST TUBES HAVE PRESENTED ISSUES. AFTER THE CLOT RETRACTS, THE SAMPLE IS CENTRIFUGED IN 3500 RPM FOR 10 MINUTES, AND THEN IT'S OBSERVED THAT THE TUBE WALL REMAINS WITH RESTS OF GEL (POOR BARRIER SEPARATION ISSUE), WHICH MAY CAUSE ERRONEOUS RESULTS IN SOME ASSAYS, JUST LIKE HIV TEST TO PRESENT VALUES WHICH THE LOW EQL READING CAUSES THE TESTS TO BE REACTIVE. THIS WAS THE CASE THAT HAPPENED ON APRIL 4 WITH A PATIENT WHICH READINGS FROM SST TUBE WERE: > 1ST: 2.26 EQL > 2ND: 2.20 EQL > FAST TEST: NOT REACTIVE ONCE THE ISSUE WAS NOTED, THE EDTA TUBE PLASMA WAS SENT TO ANOTHER LAB TO PROCESS HIV TEST, WHICH OBTAINED AS RESULTS A READING LOWER THAN OURS. THE EDTA PLASMA READING WAS 0.503 (FALSE POSITIVE FOR HIV ASSAY ISSUE) IN SOME OPPORTUNITIES WE NEED TO CENTRIFUGATE THE SAMPLES MORE THAN TWICE, DUE TO THE REMAINING REST OF GEL. AND IT HAS ALSO BEEN CAUSING A DELAY IN OUR PROCESSES.

    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 THE SAMPLE, DISCOLORED/ABNORMAL ADDITIVE FORM AND ERRONEOUS RESULTS. THE ABNORMAL ADDITIVE ISSUES AFFECTED 6000 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED, THE SST TUBES HAVE PRESENTED ISSUES AFTER THE CLOT RETRACTS. THE SAMPLE IS CENTRIFUGED IN 3500 RPM FOR 10 MINUTES. AND THEN IT'S OBSERVED, THAT THE TUBE WALL REMAINS WITH RESTS OF GEL (POOR BARRIER SEPARATION ISSUE), WHICH MAY CAUSE ERRONEOUS RESULTS IN SOME ASSAYS. JUST LIKE HIV TEST TO PRESENT VALUES, WHICH THE LOW EQL READING CAUSES THE TESTS TO BE REACTIVE. THIS WAS THE CASE THAT HAPPENED ON APRIL 4 WITH A PATIENT, WHICH READINGS FROM SST TUBE WERE: 1ST: 2.26 EQL. 2ND: 2.20 EQL. FAST TEST: NOT REACTIVE. ONCE THE ISSUE WAS NOTED, THE EDTA TUBE PLASMA WAS SENT TO ANOTHER LAB TO PROCESS HIV TEST. WHICH OBTAINED AS RESULTS A READING LOWER THAN OURS. THE EDTA PLASMA READING WAS 0.503 (FALSE POSITIVE FOR HIV ASSAY ISSUE). IN SOME OPPORTUNITIES, WE NEED TO CENTRIFUGATE THE SAMPLES MORE THAN TWICE, DUE TO THE REMAINING REST OF GEL. AND IT HAS ALSO BEEN CAUSING A DELAY IN OUR PROCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685459 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 2095159 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown