BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8464991 · Received March 29, 2019

    Report

    Report Number
    1024879-2019-00662
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 14, 2019
    Report Date
    July 26, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: "BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. 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: 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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 367986, BATCH NO. 8201552." CUSTOMER REPORTS 3 TUBES OF 367986 THAT WERE DRAWN FROM THE SAME PATIENT. SPECIMEN WAS DESCRIBED AS "NOT LOOK SO GOOD" AFTER CENTRIFUGATION. CUSTOMER STATES VIA EMAIL, "TODAY WE HAD ONE PATIENT¿S TUBE NOT LOOK SO GOOD. ALL 3 TUBES ARE FROM THE SAME PATIENT ON THE SAME COLLECTION AND SPUN 50 MINS AFTER COLLECTING. THANKS".

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 367986, BATCH NO. 8201552. -CUSTOMER REPORTS 3 TUBES OF 367986 THAT WERE DRAWN FROM THE SAME PATIENT. SPECIMEN WAS DESCRIBED AS "NOT LOOK SO GOOD" AFTER CENTRIFUGATION. CUSTOMER STATES VIA EMAIL, - "TODAY WE HAD ONE PATIENT¿S TUBE NOT LOOK SO GOOD. ALL 3 TUBES ARE FROM THE SAME PATIENT ON THE SAME COLLECTION AND SPUN 50 MINS AFTER COLLECTING. THANKS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256059 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8201552 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other