BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17432225 · Received August 1, 2023

    Report

    Report Number
    9617032-2023-01001
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 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 HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION BASED ON THE PHOTOS PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS. CUSTOMER RECOMMENDATION: SSTII¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY AT LEAST 5 COMPLETE AND GENTLE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE MINIMUM CLOTTING TIME FOR THE BD SSTII¿ TUBE (RECOMMENDED 30 MINUTE) IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING TIME) 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. ALTHOUGH FIBRIN IS A NORMAL COMPONENT OF THE CLOTTING PROCESS, THERE ARE STEPS THAT CAN BE TAKEN TO LESSEN ITS NEGATIVE EFFECTS ON SAMPLE QUALITY IN BOTH SERUM AND PLASMA. HANDLING ERRORS AND PRE-ANALYTICAL VARIABLES THAT LEAD TO FIBRIN FORMATION CAN BE ADDRESSED TO MITIGATE THE EFFECTS AND PRESENCE OF FIBRIN. THERE ARE PHYSIOLOGICAL CIRCUMSTANCES THAT MAY LEAD TO INCREASED FIBRIN, INCLUDING ANTICOAGULANT THERAPY OR A CLOTTING DISORDER MAY LEAD TO INCOMPLETE CLOTTING. 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. TO ASSURE HIGH QUALITY SPECIMENS, SEVERAL FACTORS ARE KEY. INCLUDED, BUT NOT LIMITED TO THIS ARE: PROPER PHLEBOTOMY TECHNIQUE TO MINIMIZE HEMOLYSIS AND PLATELET ACTIVATION, PROPER TUBE FILL VOLUME TO ASSURE THE PROPER BLOOD-TO-ADDITIVE RATION, GENTLE AND THOROUGH MIXING, PROPER CENTRIFUGATION CONDITIONS-G FORCE AND TIME, AND STORAGE CONDITIONS. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE, A DISCARD TUBE MUST BE USED TO FILL THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ WITH BLOOD. THE DISCARD DOES NOT NEED TO BE FILLED COMPLETELY. THE DISCARD TUBE SHOULD BE A NON-ADDITIVE OR COAGULATION TUBE. ADHERENCE TO THE RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. IN ADDITION, DRUGS/MEDICATIONS CAN CHANGE THE DENSITY OF A BLOOD SPECIMEN, FURTHER CONTRIBUTING TO THIS REPORTED CONDITION. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. ATTACHED IS OUR SST¿ TECH TALK (NOTING SSTII CENTRIFUGATION DIFFERENCE) FOR EDUCATIONAL PURPOSES.

    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. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT GEL DOES NOT SEEM TO BE FORMING A CLEAN BARRIER BETWEEN THE SERUM AND RED CELLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE GEL DOES NOT SEEM TO BE FORMING A CLEAN BARRIER BETWEEN THE SERUM AND RED CELLS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT GEL DOES NOT SEEM TO BE FORMING A CLEAN BARRIER BETWEEN THE SERUM AND RED CELLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE GEL DOES NOT SEEM TO BE FORMING A CLEAN BARRIER BETWEEN THE SERUM AND RED CELLS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337739 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2227778

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown