BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8645923 · Received May 28, 2019

    Report

    Report Number
    1024879-2019-00914
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. IT WAS DETERMINED THAT THE FOLLOWING PREPARATION PROCESS SHOULD BE FOLLOWED: SST¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY 5 COMPLETE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE RECOMMENDED 30 MINUTE MINIMUM CLOTTING TIME FOR THE BD SST¿ TUBE IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING) CAN RESULT IN THE FORMATION OF FIBRIN. THIS FIBRIN FORMATION MAY INTERFERE WITH BARRIER FORMATION. COMPLETE AND ADEQUATE BARRIER FORMATION IS TIME, TEMPERATURE AND G-FORCE DEPENDENT. POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. IT WAS DETERMINED THAT THE FOLLOWING PREPARATION PROCESS SHOULD BE FOLLOWED: SST¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY 5 COMPLETE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE RECOMMENDED 30 MINUTE MINIMUM CLOTTING TIME FOR THE BD SST¿ TUBE IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING) CAN RESULT IN THE FORMATION OF FIBRIN. THIS FIBRIN FORMATION MAY INTERFERE WITH BARRIER FORMATION. COMPLETE AND ADEQUATE BARRIER FORMATION IS TIME, TEMPERATURE AND G-FORCE DEPENDENT. POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE WAS HELD UPSIDE DOWN FOR TWO MINUTES AFTER CENTRIFUGATION FOR A SEEPAGE TEST, AND FAILED AS RED BLOOD CELLS HAD PASSED COMPLETELY THROUGH THE BARRIER INTO THE SERUM. LOT #'S 9081743 AND 9081745, WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT WITH ONE OCCURRENCE EACH, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE CONDUCTING A STUDY TO ASSESS BARRIER INTEGRITY FOR SST¿, RST, AND CPT¿. WE HAVE EXPERIENCED SOME FAILURES (RBC SEEPAGE) WHEN FOLLOWING THE IFU, PRIOR TO EVALUATION. NOTIFIED OF FAILURE (B)(6) IN THE AFTERNOON. TUBE FAILED RBC SEEPAGE TEST; HELP UPSIDE DOWN FOR TWO MINUTES AFTER CENTRIFUGATION PER THE IFU. THEN, EVALUATED FOR RBC SEEPAGE COMPLETELY THROUGH THE BARRIER FROM RBC COLUMN INTO SERUM/PLASMA COLUMN. ONE FAILURE FOR REF# 367983, LOT# 9074745, EXP 2020-02-29. TWO FAILURES FOR REF# 367986, LOT# 9081743, EXP 2020-03-31.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081743, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9081745, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-03-22. 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 · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE WAS HELD UPSIDE DOWN FOR TWO MINUTES AFTER CENTRIFUGATION FOR A SEEPAGE TEST, AND FAILED AS RED BLOOD CELLS HAD PASSED COMPLETELY THROUGH THE BARRIER INTO THE SERUM. LOT #'S 9081743 AND 9081745 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT WITH ONE OCCURRENCE EACH, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE CONDUCTING A STUDY TO ASSESS BARRIER INTEGRITY FOR SST¿, RST, AND CPT¿. WE HAVE EXPERIENCED SOME FAILURES (RBC SEEPAGE) WHEN FOLLOWING THE IFU, PRIOR TO EVALUATION. NOTIFIED OF FAILURE WEDNESDAY MAY 8TH IN THE AFTERNOON. TUBE FAILED RBC SEEPAGE TEST; HELP UPSIDE DOWN FOR TWO MINUTES AFTER CENTRIFUGATION PER THE IFU. THEN, EVALUATED FOR RBC SEEPAGE COMPLETELY THROUGH THE BARRIER FROM RBC COLUMN INTO SERUM/PLASMA COLUMN. ONE FAILURE FOR REF# 367983, LOT# 9074745, EXP 2020-02-29. TWO FAILURES FOR REF# 367986, LOT# 9081743, EXP 2020-03-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437975 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE SECTION H.10. 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other