BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 11704242 · Received April 21, 2021

    Report

    Report Number
    1917413-2021-00308
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. A COMPLAINT HISTORY WAS PERFORMED AND THIS IS THE 1ST COMPLAINT RECEIVED FOR THIS ISSUE ON THIS LOT NUMBER. CLINICAL TESTING COULD NOT BE PERFORMED AS THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT DOES NOT SPECIFICALLY CLAIM A YIELD OF CELLS RATHER A PERCENT RECOVERY OF THE PATIENT'S WHOLE BLOOD CELL COUNT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED WITH RESPECT TO POOR YIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED THEY ARE EXPERIENCING POOR PBMCS. PER PHONE CALL CUSTOMER HAD QUESTIONS IN REGARDS TO PROCESSING SPECIMENS USING CPT TUBE. CALL ORIGINALLY RECEIVED FOR TECH INQUIRY. CUSTOMER DID NOT MENTION ISSUE WITH PBMCS UNTIL CUSTOMER SPOKE WITH BD REP. RECEIVED EMAIL DOCUMENTS WHAT CUSTOMER IS EXPERIENCING. EMAIL, - CUSTOMER STATES "SORRY FOR THE DELAY IN REPLYING. PLEASE SEE THE DETAILS BELOW. THE LOT # ON THE CPT TUBES IS 0232802. SAMPLE CELL COUNT VIABILITY, PT. 001 5X10^6 55%, PT. 001 5X10^6 81%, PT. 001 5X10^6 79%, PT. 002 5X10^6 73%, PT. 002 5X10^6 20%, PT. 002 5X10^6 20%. "THE NUMBERS REPRESENT THE CPT TUBES. WE PROCESSED THE SAME PATIENT SAMPLE USING 2 ALTERNATE APPROACHES FOR PBMC ISOLATION. WE FROZE 5 MILLION CELLS PER VIAL. ON ONE HAND, WE USED TO GET AT LEAST 30 MILLION PBMCS FROM 8-10 ML OF BLOOD USING FICOLL METHOD, WE BARELY GOT 5-6 MILLION PBMCS USING CPT TUBES FROM SAME AMOUNT OF BLOOD. REGARDING THE COLLECTION AND PROCESSING, THE SAMPLES WERE PROCESSED WITHIN 2-3 HRS AFTER COLLECTION. WE RECEIVE BLOOD SAMPLES IN STRECK TUBES AND CPT TUBES. WE SPIN BOTH AT 1700G FOR 15 MIN. THE PBMCS FROM CPT TUBES ARE THEN WASHED WITH PBS, COUNTED AND FROZEN IN MR FROSTY BOX USING RECOVERY CELL FREEZING MEDIUM. FOR THE STRECK TUBES, WE SEPARATE THE PLASMA, ADD PBS AND FICOLL TO THE REMAINING FRACTION AND PROCEED WITH PBMC ISOLATION USING THE STANDARD METHOD AND FREEZE THEM AS ABOVE. ACKNOWLEDGEMENT OF COMPLAINT WAS NOT RECEIVED BY THE RCC UNTIL 29-MARCH-2021. ADDITIONAL INFORMATION RECEIVED 4/16/21: AS REPORTED BEING UPDATED TO YIELD VERSUS CELL LYSING - ISSUE IS YIELD (WHICH WE DO NOT HAVE CLAIMS FOR).

    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 WHEN USING THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED THEY ARE EXPERIENCING POOR PBMCS. PER PHONE CALL CUSTOMER HAD QUESTIONS IN REGARDS TO PROCESSING SPECIMENS USING CPT TUBE. CALL ORIGINALLY RECEIVED FOR TECH INQUIRY. CUSTOMER DID NOT MENTION ISSUE WITH PBMCS UNTIL CUSTOMER SPOKE WITH BD REP. RECEIVED EMAIL DOCUMENTS WHAT CUSTOMER IS EXPERIENCING. EMAIL, CUSTOMER STATES "SORRY FOR THE DELAY IN REPLYING. THE LOT # ON THE CPT TUBES IS (B)(4). SAMPLE CELL COUNT VIABILITY: PT. 001 5X10^6 55%, PT. 001 5X10^6 81%, PT. 001 5X10^6 79%, PT. 002 5X10^6 73%, PT. 002 5X10^6 20%, PT. 002 5X10^6 20%. "THE NUMBERS REPRESENT THE CPT TUBES. WE PROCESSED THE SAME PATIENT SAMPLE USING 2 ALTERNATE APPROACHES FOR PBMC ISOLATION. WE FROZE 5 MILLION CELLS PER VIAL. ON ONE HAND, WE USED TO GET AT LEAST 30 MILLION PBMCS FROM 8-10 ML OF BLOOD USING FICOLL METHOD, WE BARELY GOT 5-6 MILLION PBMCS USING CPT TUBES FROM SAME AMOUNT OF BLOOD. REGARDING THE COLLECTION AND PROCESSING, THE SAMPLES WERE PROCESSED WITHIN 2-3 HRS AFTER COLLECTION. WE RECEIVE BLOOD SAMPLES IN STRECK TUBES AND CPT TUBES. WE SPIN BOTH AT 1700G FOR 15 MIN. THE PBMCS FROM CPT TUBES ARE THEN WASHED WITH PBS, COUNTED AND FROZEN IN MR FROSTY BOX USING RECOVERY CELL FREEZING MEDIUM. FOR THE STRECK TUBES, WE SEPARATE THE PLASMA, ADD PBS AND FICOLL TO THE REMAINING FRACTION AND PROCEED WITH PBMC ISOLATION USING THE STANDARD METHOD AND FREEZE THEM AS ABOVE. ACKNOWLEDGEMENT OF COMPLAINT WAS NOT RECEIVED BY THE RCC UNTIL 29-MARCH-2021. ADDITIONAL INFORMATION RECEIVED 4/16/21: AS REPORTED BEING UPDATED TO YIELD VERSUS CELL LYSING, ISSUE IS YIELD (WHICH WE DO NOT HAVE CLAIMS FOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600744 BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362761 0232802 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1