BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML

    MDR report key: 9706843 · Received February 13, 2020

    Report

    Report Number
    1917413-2020-00115
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 25, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : 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 SAMPLE QUALITY 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 A CAPA # 373360. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ARE YOU ABLE TO HELP US WITH A COMPLAINT RE THE BD VACUTAINERS? MORE OF OUR SITES ARE DISCOVERING ISSUES WITH THE TUBES IN THAT THE MONONUCLEAR LAYERS ARE NOT SEPARATING IN SOME TUBES AND ARE IN OTHERS (DURING THE SAME PROCESSING). THIS IS AN ISSUE FOR US AS WE HAVE NOT MANY ISSUES AND THESE SAMPLES ARE CRUCIAL FOR OUR RESEARCH. ONCE WE ARE PUT IN TOUCH WITH THE CORRECT PERSON, WE WILL SEND DETAILS INCLUDING BATCH NUMBERS OF AFFECTED TUBES."

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #S: 8243918, 9122989; ADDITIONAL EXPIRATION DATES: 2019-09-30, 2020-05-31. (B)(6). ADDITIONAL MANUFACTURE DATES: 2018-08-31, 2019-05-02. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ARE YOU ABLE TO HELP US WITH A COMPLAINT RE THE BD VACUTAINERS? MORE OF OUR SITES ARE DISCOVERING ISSUES WITH THE TUBES IN THAT THE MONONUCLEAR LAYERS ARE NOT SEPARATING IN SOME TUBES AND ARE IN OTHERS (DURING THE SAME PROCESSING). THIS IS AN ISSUE FOR US AS WE HAVE NOT MANY ISSUES AND THESE SAMPLES ARE CRUCIAL FOR OUR RESEARCH. ONCE WE ARE PUT IN TOUCH WITH THE CORRECT PERSON, WE WILL SEND DETAILS INCLUDING BATCH NUMBERS OF AFFECTED TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172946 BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9024515

    Patients

    Seq Age Sex Outcome Treatment
    1 Other