BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 9820960 · Received March 11, 2020

    Report

    Report Number
    1024879-2020-00197
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 21, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 OF RED CELL HANGUP (BASED ON THE PHOTOS PROVIDED) WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 9154515, REORDER NUMBER 367983. 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. THE PHOTOGRAPHS INDICATE RED CELL HANGUP (FIBRIN WITH RED CELL FRAGMENTS). CLOTTING IN AN UPRIGHT POSTURE WILL HELP MITIGATE THE OCCURRENCE OF RED CELL HANGUP. IN ADDITION, CENTRIFUGATION AT 3000 RCG (G) FOR 10 MINUTES IN A SWING BUCKET OR 15 MINUTES IN FIXED ANGLE CENTRIFUGE WILL, IN MOST CASES PRECLUDE THIS SCENARIO. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR MONITORING OF CURRENT TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POOR SEPARATION OCCURRED AFTER USE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER USED TO BE ANOTHER COMPANIES CUSTOMER AND WE COULD CONVERT THE ACCOUNT. WE STARTED THE IMPLEMENTATION PROCESS WHICH INCLUDES THE BEGINNING OF SST TUBE USE IN ALL PATIENT SERVICE CENTERS. BEFORE STARTING TO USE BD TUBES, WE PROVIDED TRAINING TO THE ENTIRE TEAM OF PHLEBOTOMISTS, INCLUDING TECHNICIANS WHO CENTRIFUGE SAMPLES. DURING THE IMPLEMENTATION, CLINICAL CONSULTANTS FROM BD TEAM OBSERVED BLOOD COLLECTION PROCEDURES AND DETECTED A VERY GOOD PROCESS, FOLLOWING BD¿S RECOMMENDATION OF PRODUCT USE. EVEN AFTER ALL THOSE ACTIONS, WE ARE SEEING A HIGH LEVEL OF FIBRIN STRANDS FORMATION (25% OF TOTAL) AND DIFFICULTIES TO DILUTE THE CLOT ACTIVATOR AFTER MIXING PROPERLY THE TUBES. WE ARE WONDERING THE RELATION OF FIBRIN STRANDS WITH RESIDUAL CLOT ACTIVATOR. IN THE NEXT SLIDES YOU CAN FIND PICTURES FROM TUBES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 POOR SEPARATION OCCURRED AFTER USE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER USED TO BE ANOTHER COMPANIES CUSTOMER AND WE COULD CONVERT THE ACCOUNT. WE STARTED THE IMPLEMENTATION PROCESS WHICH INCLUDES THE BEGGINING OF SST TUBE USE IN ALL PATIENT SERVICE CENTERS. BEFORE STARTING TO USE BD TUBES, WE PROVIDED TRAINING TO THE ENTIRE TEAM OF PHLEBOTOMISTS, INCLUDING TECHNICIANS WHO CENTRIFUGE SAMPLES. DURING THE IMPLEMENTATION, CLINICAL CONSULTANTS FROM BD TEAM OBSERVED BLOOD COLLECTION PROCEDURES AND DETECTED A VERY GOOD PROCESS, FOLLOWING BD¿S RECOMMENDATION OF PRODUCT USE. EVEN AFTER ALL THOSE ACTIONS, WE ARE SEEING A HIGH LEVEL OF FIBRIN STRANDS FORMATION (25% OF TOTAL) AND DIFFICULTIES TO DILUTE THE CLOT ACTIVATOR AFTER MIXING PROPERLY THE TUBES. WE ARE WONDERING THE RELATION OF FIBRIN STRANDS WITH RESIDUAL CLOT ACTIVATOR. IN THE NEXT SLIDES YOU CAN FIND PICTURES FROM TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285184 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367983 9154515 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other