BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9438500 · Received December 9, 2019

    Report

    Report Number
    1024879-2019-02091
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 21, 2019
    Report Date
    February 3, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD ACKNOWLEDGES THE CUSTOMER'S EXPERIENCE REGARDING THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT 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. POOR BARRIER SEPARATION 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 POOR BARRIER SEPARATION 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 POOR BARRIER SEPARATION . H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBE HAD AN INCOMPLETE GEL MIGRATION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINS OF INCOMPLETE GEL MIGRATION DESPITE PROPER PRE-ANALYTICAL HANDLING. ADDITIONAL INFORMATION RECEIVED: ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) NO. WAS FIBRIN PRESENT IN THE SERUM? NO. WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? YES. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? 3500 RPM. WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? SWING. WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES. IS THE CENTRIFUGE TEMPERATURE CONTROLLED? IF SO, TO WHAT TEMPERATURE IS IT SET? NO TEMP CONTROL. ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? YES VIA COURIER. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? YES. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? (B)(6) 2018. WHAT WAS STORAGE CONDITIONS? WHERE THEY STORED IN REFRIGERATOR PRIOR TO USE? NO.

    Additional Manufacturer Narrative · 1

    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 THE TUBE HAD AN INCOMPLETE GEL MIGRATION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINS OF INCOMPLETE GEL MIGRATION DESPITE PROPER PRE-ANALYTICAL HANDLING. ADDITIONAL INFORMATION RECEIVED: ARE PATIENT IDENTIFIERS KNOWN? IF SO, PLEASE PROVIDE (GENDER, AGE, DOB, WEIGHT, ETC.) NO. WAS FIBRIN PRESENT IN THE SERUM? NO. WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? YES. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? 3500 RPM. WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? SWING. WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES. IS THE CENTRIFUGE TEMPERATURE CONTROLLED? IF SO, TO WHAT TEMPERATURE IS IT SET? NO TEMP CONTROL. ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? YES VIA COURIER. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? YES. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? DECEMBER 2018. WHAT WAS STORAGE CONDITIONS? WHERE THEY STORED IN REFRIGERATOR PRIOR TO USE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236945 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367983 9164892 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other