BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 10459981 · Received August 27, 2020

    Report

    Report Number
    1024879-2020-00602
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 6, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES AND 1 PHOTO FOR THE INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY, WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1211 RCF FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL 4 TUBES WERE FOUND TO HAVE GOOD GEL SEPARATION. RETURNED SAMPLES WERE UNABLE TO BE TESTED DUE TO AN INTERNAL ISSUE AFTER RECEIPT OF SPECIMENS. 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 BASED ON THE PHOTO PROVIDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS POOR BARRIER SEPARATION AFTER CENTRIFUGE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED AFTER SPINNING THE BLOOD IS CREEPING UP THE GEL BACK INTO THE SERUM. ADDITIONALLY, ON 2020-08-10 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THERE MULTIPLE PATIENTS INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES, THERE WERE MULTIPLE TUBES INVOLVED. ARE PATIENT IDENTIFIERS AVAILABLE? IF SO, PLEASE PROVIDE A FEW (GENDER, DOB, AGE, WEIGHT, ETC.) NO, WE ARE UNABLE TO PROVIDE PATIENT INFORMATION DUE TO HOSPITAL PROTOCOL. WHAT IS THE PRODUCT PART AND BATCH NUMBER? LOT 0080927 X: 3/31/2021. REF (B)(4). WHAT IS THE DATE OF EVENT(S)? BEGAN THURSDAY (B)(6) 2020. CONTINUES TO PRESENT. WAS THE TUBE MIXED PROPERLY AFTER THE COLLECTION? YES. THIS ISSUE WAS SEEN IN TUBES THAT WERE COLLECTED BY PHLEBOTOMISTS WHO ARE TRAINED TO MIX TUBES FOLLOWING COLLECTION. HOW LONG WAS THE SAMPLE ALLOWED TO CLOT? ON AVERAGE SAMPLES SIT AT ROOM TEMPERATURE FOR 30 MINUTES PRIOR TO CENTRIFUGATION. WAS FIBRIN PRESENT IN THE SERUM? FEW FIBRIN STRANDS WERE NOTED IN SOME SPECIMENS, BUT NOT IN ALL THE SAMPLES AFFECTED. WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? 5. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? CENTRIFUGE SPEED IS 3000 RPM FOR 10 MINUTES. WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? CALIBRATION WAS PERFORMED ON (B)(6), 2020 WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? SWING BUCKET. WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES. IS THE CENTRIFUGE TEMPERATURE CONTROLLED? IF SO, TO WHAT TEMPERATURE IS IT SET? NO. WHAT DID THE GEL BARRIER LOOK LIKE (SLANTED OR FLAT; COMPLETE OR PARTIAL; GEL ON THE WALLS; GEL REMAINING ON THE BASE OF THE TUBE)? WAS THERE A COMPLETE BARRIER? THE GEL BARRIER IS FLAT, AND A COMPLETE BARRIER. THERE ARE STEAKS FOR RBCS VISIBLE THROUGHOUT THE GEL FROM THE BOTTOM, THROUGH TO THE TOP WHERE THE SERUM IS. DOES THE POOR BARRIER APPEAR IN ALL TUBES OR ONLY OCCASIONALLY? OCCASIONALLY. ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? SPECIMENS FROM THE INPATIENT FLOORS ARE CARRIED BY HAND. SPECIMENS FROM THE EMERGENCY ROOM ARE RECEIVED BY PNEUMATIC TUBE. SPECIMENS FROM OUTPATIENT PHLEBOTOMY ARE RECEIVED BY ROBOTIC TUG SYSTEM. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? TUBES ARE STORED AT ROOM TEMP, IN THE STOCK ROOM AND IN CABINETS IN PHLEBOTOMY. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? NO. IS TUBE STORE UPRIGHT OR ON ITS SIDE, AFTER COLLECTION? TUBES ARE STORED UPRIGHT IN RACKS. ARE UNUSED SAMPLES OF THE RELATED BATCH/LOT NUMBER FOR INVESTIGATION? IF YES, I WILL PROVIDE YOU A PREPAID SHIPPING LABEL. YES, UNUSED TUBES ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS POOR BARRIER SEPARATION AFTER CENTRIFUGE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED AFTER SPINNING THE BLOOD IS CREEPING UP THE GEL BACK INTO THE SERUM. ADDITIONALLY, ON 2020-08-10 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THERE MULTIPLE PATIENTS INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES, THERE WERE MULTIPLE TUBES INVOLVED ARE PATIENT IDENTIFIERS AVAILABLE? IF SO, PLEASE PROVIDE A FEW (GENDER, DOB, AGE, WEIGHT, ETC.) NO, WE ARE UNABLE TO PROVIDE PATIENT INFORMATION DUE TO HOSPITAL PROTOCOL WHAT IS THE PRODUCT PART AND BATCH NUMBER? LOT 0080927 X: 3/31/2021 REF 367986 WHAT IS THE DATE OF EVENT(S)? BEGAN THURSDAY (B)(6) 2020 CONTINUES TO PRESENT WAS THE TUBE MIXED PROPERLY AFTER THE COLLECTION? YES. THIS ISSUE WAS SEEN IN TUBES THAT WERE COLLECTED BY PHLEBOTOMISTS WHO ARE TRAINED TO MIX TUBES FOLLOWING COLLECTION HOW LONG WAS THE SAMPLE ALLOWED TO CLOT? ON AVERAGE SAMPLES SIT AT ROOM TEMPERATURE FOR 30 MINUTES PRIOR TO CENTRIFUGATION WAS FIBRIN PRESENT IN THE SERUM? FEW FIBRIN STRANDS WERE NOTED IN SOME SPECIMENS, BUT NOT IN ALL THE SAMPLES AFFECTED WERE THE RECOMMENDED CENTRIFUGATION G-FORCE, TIME, AND TEMPERATURE OBSERVED? 5. WHAT IS THE CENTRIFUGATION RAMP-UP SPEED? CENTRIFUGE SPEED IS 3000 RPM FOR 10 MINUTES WHEN WAS THE CALIBRATION OF THE CENTRIFUGE LAST CHECKED? CALIBRATION WAS PERFORMED ON AUGUST 1, 2020 WHAT TYPE OF CENTRIFUGE WAS USED- FIXED ANGLE OR SWING BUCKET? SWING BUCKET WERE THE CENTRIFUGE SLEEVES BALANCED TO ASSURE PROPER PERFORMANCE? YES IS THE CENTRIFUGE TEMPERATURE CONTROLLED? IF SO, TO WHAT TEMPERATURE IS IT SET? NO WHAT DID THE GEL BARRIER LOOK LIKE (SLANTED OR FLAT; COMPLETE OR PARTIAL; GEL ON THE WALLS; GEL REMAINING ON THE BASE OF THE TUBE)? WAS THERE A COMPLETE BARRIER? THE GEL BARRIER IS FLAT, AND A COMPLETE BARRIER. THERE ARE STEAKS FOR RBCS VISIBLE THROUGHOUT THE GEL FROM THE BOTTOM, THROUGH TO THE TOP WHERE THE SERUM IS DOES THE POOR BARRIER APPEAR IN ALL TUBES OR ONLY OCCASIONALLY? OCCASIONALLY ARE THE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, HAND CARRIED, COURIER, GROUND VS. AIR)? SPECIMENS FROM THE INPATIENT FLOORS ARE CARRIED BY HAND SPECIMENS FROM THE EMERGENCY ROOM ARE RECEIVED BY PNEUMATIC TUBE SPECIMENS FROM OUTPATIENT PHLEBOTOMY ARE RECEIVED BY ROBOTIC TUG SYSTEM ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? TUBES ARE STORED AT ROOM TEMP, IN THE STOCK ROOM AND IN CABINETS IN PHLEBOTOMY DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? NO IS TUBE STORE UPRIGHT OR ON ITS SIDE, AFTER COLLECTION? TUBES ARE STORED UPRIGHT IN RACKS ARE UNUSED SAMPLES OF THE RELATED BATCH/LOT NUMBER FOR INVESTIGATION? IF YES, I WILL PROVIDE YOU A PREPAID SHIPPING LABEL. YES, UNUSED TUBES ARE AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928140 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 0080927 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other