BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8495465 · Received April 9, 2019

    Report

    Report Number
    1024879-2019-00710
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 12, 2019
    Report Date
    May 30, 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
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. 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. 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: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. THIS COMPLAINT INVESTIGATION WAS CONDUCTED UNDER THE PREMISE OF A PREVIOUSLY INVESTIGATED ISSUE SPECIFIC FOR POOR BARRIER SEPARATION, WHERE IT WAS DETERMINED THAT THE RESULTS AND CONCLUSIONS ESTABLISHED IN THE PREVIOUS INVESTIGATIONS POINTED TO THE SAME INDICATED FAILURE MODE AND ROOT CAUSES OBSERVED IN THE CURRENT COMPLAINT INVESTIGATION. ADDITIONALLY, THE CONCLUSION DRAWN FROM THE CURRENT COMPLAINT INVESTIGATION DID NOT YIELD NEW INFORMATION REGARDING THE INDICATED FAILURE MODE. COMPLAINT DATA FOR THIS FAILURE MODE IS MONITORED AND TRENDED ON A ROUTINE BASIS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. THIS COMPLAINT INVESTIGATION WAS CONDUCTED UNDER THE PREMISE OF A PREVIOUSLY INVESTIGATED ISSUE SPECIFIC FOR POOR BARRIER SEPARATION, WHERE IT WAS DETERMINED THAT THE RESULTS AND CONCLUSIONS ESTABLISHED IN THE PREVIOUS INVESTIGATIONS POINTED TO THE SAME INDICATED FAILURE MODE AND ROOT CAUSES OBSERVED IN THE CURRENT COMPLAINT INVESTIGATION. ADDITIONALLY, THE CONCLUSION DRAWN FROM THE CURRENT COMPLAINT INVESTIGATION DID NOT YIELD NEW INFORMATION REGARDING THE INDICATED FAILURE MODE. COMPLAINT DATA FOR THIS FAILURE MODE IS MONITORED AND TRENDED ON A ROUTINE BASIS. 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 UNDERFILL AND POOR SEPARATION OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, " MATERIAL NO. 367986, BATCH NO. 8347813. IT WAS REPORTED THAT THE GOLD TOP TUBES WERE NOT SPINNING DOWN. "HELLO, WELL THINGS HAVE PROGRESSED SINCE LAST WEEK. I BELIEVE THE CUSTOMER ALREADY SENT YOU BACK SOME TUBES FROM FIRST AFFECTED LOT. SINCE THEN WE HAVE FOUND ANOTHER THREE LOTS SO MAY NEED A LITTLE ASSISTANCE FROM BD ON THIS. I DO HAVE ONE UNUSED PACKING LABEL IF YOU WISH THAT WE TRY TO SEND MULTIPLE LOT EXAMPLES, OR JUST WAIT TO HEAR BACK REGARDING A POTENTIAL SHIPPING TEMPERATURE ISSUE. LOTS SO FAR SEEM TO BE 8292794, 8255914, 8347813, AND 8220938. WONDERING NOW IF PRODUCT BEING FROZEN IN TRANSIT COULD CAUSE ANY OF THIS. I HAVE NO CONFIRMATION THAT THIS OCCURRED, JUST THINKING YOU WOULD HAVE SEEN THIS AND KNOW WHAT TO LOOK FOR. IT COMES TO MIND AS THIS IS AN ISSUE WITH OTHER REAGENTS IN THE WINTER. IF NOT, WE CAN AT LEAST RULE IT OUT. IT WAS QUITE COLD THIS WINTER AND EVEN OVER THE PAST FEW WEEKS. SOME OF THESE TUBES HAVE BEEN CENTRIFUGED A NUMBER OF TIMES AND STILL NOT WORK APPROPRIATELY, ALTHOUGH IT IS SPORADIC. IN ONE INSTANCE THE CORVAC ENDED UP TOWARD THE TUBE CAP AND WAS IN MANY PIECES. PLEASE ADVISE, THANKS." ADDITIONAL INFORMATION RECEIVED: WE COULD NEVER TEST FROM THE PRIMARY TUBE DUE TO LACK OF SAMPLE VOLUME DUE TO LACK OF GEL SEPARATION. WHEN THE TUBES SPIN THERE IS A SMALL RED BUTTON ON THE VERY BOTTOM, WITH GEL JUST ABOVE, THEN A ¿RED¿ LAYER OF CELLS AND DEBRIS ON TOP OF THE GEL. WE HAD TO REMOVE AS MUCH OF THE CELLS AND SERUM AS POSSIBLE FROM THE PRIMARY TUBE AND THEN SPIN THAT AND SEPARATE INTO ANOTHER PLAIN TUBE FOR TESTING."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 UNDERFILL AND POOR SEPARATION OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, ''MATERIAL NO. 367986, BATCH NO. 8347813''. IT WAS REPORTED THAT THE GOLD TOP TUBES WERE NOT SPINNING DOWN. "HELLO, WELL THINGS HAVE PROGRESSED SINCE LAST WEEK. I BELIEVE THE CUSTOMER ALREADY SENT YOU BACK SOME TUBES FROM FIRST AFFECTED LOT. SINCE THEN WE HAVE FOUND ANOTHER THREE LOTS SO MAY NEED A LITTLE ASSISTANCE FROM BD ON THIS. I DO HAVE ONE UNUSED PACKING LABEL IF YOU WISH THAT WE TRY TO SEND MULTIPLE LOT EXAMPLES, OR JUST WAIT TO HEAR BACK REGARDING A POTENTIAL SHIPPING TEMPERATURE ISSUE. LOTS SO FAR SEEM TO BE 8292794, 8255914, 8347813, AND 8220938. WONDERING NOW IF PRODUCT BEING FROZEN IN TRANSIT COULD CAUSE ANY OF THIS. I HAVE NO CONFIRMATION THAT THIS OCCURRED, JUST THINKING YOU WOULD HAVE SEEN THIS AND KNOW WHAT TO LOOK FOR. IT COMES TO MIND AS THIS IS AN ISSUE WITH OTHER REAGENTS IN THE WINTER. IF NOT, WE CAN AT LEAST RULE IT OUT. IT WAS QUITE COLD THIS WINTER AND EVEN OVER THE PAST FEW WEEKS. SOME OF THESE TUBES HAVE BEEN CENTRIFUGED A NUMBER OF TIMES AND STILL NOT WORK APPROPRIATELY, ALTHOUGH IT IS SPORADIC. IN ONE INSTANCE THE CORVAC ENDED UP TOWARD THE TUBE CAP AND WAS IN MAY PIECES. PLEASE ADVISE, THANKS." ADDITIONAL INFORMATION RECEIVED: WE COULD NEVER TEST FROM THE PRIMARY TUBE DUE TO LACK OF SAMPLE VOLUME DUE TO LACK OF GEL SEPARATION. WHEN THE TUBES SPIN THERE IS A SMALL RED BUTTON ON THE VERY BOTTOM, WITH GEL JUST ABOVE, THEN A ¿RED¿ LAYER OF CELLS AND DEBRIS ON TOP OF THE GEL. WE HAD TO REMOVE AS MUCH OF THE CELLS AND SERUM AS POSSIBLE FROM THE PRIMARY TUBE AND THEN SPIN THAT AND SEPARATE INTO ANOTHER PLAIN TUBE FOR TESTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287708 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8347813 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other