BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD CCFDNA TUBE

    MDR report key: 15343871 · Received September 2, 2022

    Report

    Report Number
    9617032-2022-00814
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 16, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2020649, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2022-01-20. MEDICAL DEVICE LOT #: 1299729, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2021-10-26.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO CLOTTING WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL RETAINED TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, CLOTTING, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETAINED LOT SAMPLES. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO CLOTTING WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE BLOOD CLOTTING DURING CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 17 AUG: FURTHER INFORMATION: AS BACKGROUND, THE TUBES ARE BEING USED FOR SAMPLES IN TWO CLINICAL RESEARCH TRIALS. I COORDINATE THE SUPPLIES FOR HOSPITALS PARTICIPATING IN THE TRIALS ACROSS THE WHOLE OF THE UK; SO I ORDER THE TUBES AND THEN DISTRIBUTE THEM TO ALL THE HOSPITAL SITES. ONCE THE BLOOD IS COLLECTED, THE BLOOD SAMPLES ARE RETURNED TO THE LAB IN OXFORD FOR PROCESSING. WE KEEP A CLOSE EYE ON THE DATE THE SAMPLE WAS COLLECTED TO ENSURE IT IS WITHIN THE 7 DAY STABILITY WINDOW. WE COLLECT TWO PAXGENE CFDNA BLOOD SAMPLES PER PATIENT RECRUITED TO THE STUDIES AND RECENTLY THE LAB TEAM HAVE SEEN THAT SOMETIMES JUST ONE OF THE TWO BLOOD TUBES CLOTS SO WE DON¿T EXPECT THERE TO BE AN ISSUE WITH THE WAY THE BLOOD IS COLLECTED AT THE SITES. THE LOT NO. FOR THE FIRST ORDER WE PLACED IS 2020649, AND THE SECOND ORDER IS 1299729. I BELIEVE THE ISSUES WILL MOSTLY BE AFFECTING LOT NO 2020649 AS THESE ARE THE ONES I DISTRIBUTED FIRST. THE LAB TEAM HAVE NOT TAKEN PHOTOS BUT THEY WILL DO IF THE CLOTTING HAPPENS AGAIN. IF IT IS EASIER, THE LAB TEAM HAVE CONFIRMED THEY ARE HAPPY TO HAVE A TEAMS CALL TO EXPLAIN WHAT IS HAPPENING HERE. WE HAVE PREVIOUSLY USED LBGARD TUBES FOR CFDNA SAMPLE COLLECTION AND HAD NO ISSUES WHEN IT CAME TO PROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE BLOOD CLOTTING DURING CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 17 AUG: FURTHER INFORMATION: AS BACKGROUND, THE TUBES ARE BEING USED FOR SAMPLES IN TWO CLINICAL RESEARCH TRIALS. I COORDINATE THE SUPPLIES FOR HOSPITALS PARTICIPATING IN THE TRIALS ACROSS THE WHOLE OF THE UK; SO I ORDER THE TUBES AND THEN DISTRIBUTE THEM TO ALL THE HOSPITAL SITES. ONCE THE BLOOD IS COLLECTED, THE BLOOD SAMPLES ARE RETURNED TO THE LAB IN OXFORD FOR PROCESSING. WE KEEP A CLOSE EYE ON THE DATE THE SAMPLE WAS COLLECTED TO ENSURE IT IS WITHIN THE 7 DAY STABILITY WINDOW. WE COLLECT TWO PAXGENE CFDNA BLOOD SAMPLES PER PATIENT RECRUITED TO THE STUDIES AND RECENTLY THE LAB TEAM HAVE SEEN THAT SOMETIMES JUST ONE OF THE TWO BLOOD TUBES CLOTS SO WE DON¿T EXPECT THERE TO BE AN ISSUE WITH THE WAY THE BLOOD IS COLLECTED AT THE SITES. THE LOT NO. FOR THE FIRST ORDER WE PLACED IS 2020649, AND THE SECOND ORDER IS 1299729. I BELIEVE THE ISSUES WILL MOSTLY BE AFFECTING LOT NO 2020649 AS THESE ARE THE ONES I DISTRIBUTED FIRST. THE LAB TEAM HAVE NOT TAKEN PHOTOS BUT THEY WILL DO IF THE CLOTTING HAPPENS AGAIN. IF IT IS EASIER, THE LAB TEAM HAVE CONFIRMED THEY ARE HAPPY TO HAVE A TEAMS CALL TO EXPLAIN WHAT IS HAPPENING HERE. WE HAVE PREVIOUSLY USED LBGARD TUBES FOR CFDNA SAMPLE COLLECTION AND HAD NO ISSUES WHEN IT CAME TO PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677667 PAXGENE® BLOOD CCFDNA TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1299729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown