BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8392109 · Received March 5, 2019

    Report

    Report Number
    9617032-2019-00267
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 18, 2019
    Report Date
    April 10, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    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

    THE FOLLOWING FIELD WAS CHANGED DUE TO CORRECTED INFORMATION: METHOD CODES: 4114.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BD TECHNICAL SUPPORT SERVICES HAD REACHED OUT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. IT WAS NOTED THAT THE CUSTOMER IS WELL AWARE OF THE FACTORS THAT CAN CAUSE HEMOLYSIS AND IS TRYING TO PREVENT THEM. BD WILL CONTINUE TO WORK WITH THE CUSTOMER AS THERE ARE EDUCATIONAL OPPORTUNITIES TO HAVE A CLINICAL CONSULTANT WORK WITH THEIR CLINICS WHERE HIGH HEMOLYSIS RATES ARE OBSERVED. CUSTOMER IS ALSO OPEN TO EXPLORING ALTERNATE BD ACQUISITION PRODUCTS SUCH AS PBBCS ULTRATOUCH. HEMOLYSIS CAN BE CAUSED BY MANY SOURCES, INCLUDING CERTAIN PATIENT PATHOLOGICAL CONDITIONS, IMPROPER SPECIMEN COLLECTION, SPECIMEN PROCESSING, AND SPECIMEN TRANSPORT. SPECIMEN COLLECTION FACTORS THAT CAN CONTRIBUTE TO HEMOLYSIS RANGE FROM PROLONGED TOURNIQUET TIME AND IMPROPER VENIPUNCTURE TECHNIQUE TO TRANSFERRING A SAMPLE FROM A SYRINGE DRAW OR IV CATHETER. SPECIMEN PROCESSING FACTORS INCLUDE VIGOROUS MIXING OR SHAKING OF THE SPECIMEN, NOT ALLOWING THE SPECIMEN TO CLOT FOR THE RECOMMENDED AMOUNT OF TIME, PROLONGED CONTACT OF SERUM OR PLASMA WITH CELLS, AND EXPOSURE TO EXCESSIVE HEAT OR COLD. FINALLY, MECHANICAL TRAUMA AND OTHER ADVERSE CONDITIONS DURING TRANSPORT OF TUBES CAN RESULT IN HEMOLYSIS. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. 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 A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD HEMOLYTIC ISSUE. CUSTOMER ALSO STATED THAT CUSTOMER ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND THE TECH MIGHT HAVE HIGHER HEMOLYSIS RATE ON CHEMISTRY TUBE EVEN AFTER EDUCATION. PATIENT STATED THAT HEMOLYSIS PROBLEMS WERE OCCURRED MORE IN ANALYZING K+, MG 2+, AST, ALT, LDH, AND OTHER ¿ MATERIAL NO: 368879 ; BATCH NO: UNKNOWN. IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES:¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD HEMOLYTIC ISSUE. CUSTOMER ALSO STATED THAT CUSTOMER ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND THE TECH MIGHT HAVE HIGHER HEMOLYSIS RATE ON CHEMISTRY TUBE EVEN AFTER EDUCATION. PATIENT STATED THAT HEMOLYSIS PROBLEMS WERE OCCURRED MORE IN ANALYZING K+, MG 2+, AST, ALT, LDH, AND OTHER ¿ MATERIAL NO: 368879 ; BATCH NO: UNKNOWN. IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES:¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD HEMOLYTIC ISSUE. CUSTOMER ALSO STATED THAT CUSTOMER ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND THE TECH MIGHT HAVE HIGHER HEMOLYSIS RATE ON CHEMISTRY TUBE EVEN AFTER EDUCATION. PATIENT STATED THAT HEMOLYSIS PROBLEMS WERE OCCURRED MORE IN ANALYZING K+, MG 2+, AST, ALT, LDH, AND OTHER. CUSTOMER¿S VERBATIM: ¿ MATERIAL NO: 368879, BATCH NO: UNKNOWN. IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES:¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185992 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other