BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 9445130 · Received December 10, 2019

    Report

    Report Number
    1917413-2019-02507
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 FOR LOW YIELD WITH THE INCIDENT LOT WAS OBSERVED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#1092363. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE. MEDICAL DEVICE CATALOG #: 362760. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31 . MEDICAL DEVICE LOT #: 8340765. UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA/510(K)#: K911731.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN HAD A LOW YIELD. THIS OCCURRED ON (B)(4) OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 362753, BATCH NO. UNKNOWN -IT IS REPORTED CUSTOMER IS EXPERIENCING POOR CELL RECOVERY WHEN USING CPT VACUTAINERS. WE ARE PROCESSING FOR PBMCS USING THE BELOW PROTOCOL AND WE HAVE HAD SOME ISSUES WITH THE TUBES SOMETIMES NOT LAYERING WELL. IF IT HAPPENS IT¿S USUALLY ONLY 1-2 TUBES OUT OF THE 6 WE COLLECT, SO SHOULD THESE TUBES BE RE-CENTRIFUGED (AND AT WHAT SPEED/DURATION) AND WHY DOES THIS OCCUR? HOW DOES THIS PROTOCOL LOOK, ARE THERE ANY GLARING ISSUES? WE HAVE ALSO HAD SOME VARIANCE WITH OUR VIABILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD A LOW YIELD. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 362760, BATCH NO. 8340765. IT IS REPORTED CUSTOMER IS EXPERIENCING POOR CELL RECOVERY WHEN USING CPT VACUTAINERS. WE ARE PROCESSING FOR PBMCS USING THE BELOW PROTOCOL AND WE HAVE HAD SOME ISSUES WITH THE TUBES SOMETIMES NOT LAYERING WELL. IF IT HAPPENS IT¿S USUALLY ONLY 1-2 TUBES OUT OF THE 6 WE COLLECT, SO SHOULD THESE TUBES BE RE-CENTRIFUGED (AND AT WHAT SPEED/DURATION) AND WHY DOES THIS OCCUR? HOW DOES THIS PROTOCOL LOOK, ARE THERE ANY GLARING ISSUES? WE HAVE ALSO HAD SOME VARIANCE WITH OUR VIABILITY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN HAD A LOW YIELD. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 362753, BATCH NO. UNKNOWN. IT IS REPORTED CUSTOMER IS EXPERIENCING POOR CELL RECOVERY WHEN USING CPT VACUTAINERS. WE ARE PROCESSING FOR PBMCS USING THE BELOW PROTOCOL AND WE HAVE HAD SOME ISSUES WITH THE TUBES SOMETIMES NOT LAYERING WELL. IF IT HAPPENS IT¿S USUALLY ONLY 1-2 TUBES OUT OF THE 6 WE COLLECT, SO SHOULD THESE TUBES BE RE-CENTRIFUGED (AND AT WHAT SPEED/DURATION) AND WHY DOES THIS OCCUR? HOW DOES THIS PROTOCOL LOOK, ARE THERE ANY GLARING ISSUES? WE HAVE ALSO HAD SOME VARIANCE WITH OUR VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243327 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362753 8340765 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other