BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD CCFDNA TUBE

    MDR report key: 12197158 · Received July 20, 2021

    Report

    Report Number
    9617032-2021-00802
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 30, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS WAS OBSERVED. ADDITIONALLY, 5 RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR HEMOLYSIS WAS OBSERVED. ALL TUBES FILLED AS EXPECTED AND VISUAL INSPECTION FOUND NO CLOTS. VISUAL INSPECTION OF THE RETAINED AND CONTROL TUBES CONFIRMED THE REPORTED DEFECTS. ROOT CAUSE COULD NOT BE DETERMINED. BD WAS ABLE TO CONFIRM THE CUSTOMERS¿ INDICATED FAILURE, HEMOLYSIS, BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE RETAINED LOT SAMPLES. VISUAL EVALUATION OF THE CONTROL SAMPLES FOR HEMOLYSIS DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 THEREFORE CONFIRMED WITH RESPECT TO HEMOLYSIS IN LOT 0133849. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A TREND WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A CUSTOMER COMPLAINT ABOUT HEMOLYSIS WITH TWO PAXGENE BLOOD CCFDNA TUBES .

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A CUSTOMER COMPLAINT ABOUT HEMOLYSIS WITH TWO PAXGENE BLOOD CCFDNA TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097527 PAXGENE® BLOOD CCFDNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 0133849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown