BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD CCFDNA TUBE

    MDR report key: 19396473 · Received May 24, 2024

    Report

    Report Number
    9617032-2024-00809
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 9, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    04053727681652
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: D4. MEDICAL DEVICE LOT #: 2020649 D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2023 H4. DEVICE MANUFACTURE DATE: 20-JAN-2022 D4. MEDICAL DEVICE LOT #: 2111720 D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2023 H4. DEVICE MANUFACTURE DATE: 21-APR-2022 D4. MEDICAL DEVICE LOT #: 2307888 D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024 H4. DEVICE MANUFACTURE DATE: 03-NOV-2022 D4. MEDICAL DEVICE LOT #: 3012269 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024 H4. DEVICE MANUFACTURE DATE: 12-JAN-2023 D4. MEDICAL DEVICE LOT #: 3167402 D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024 H4. DEVICE MANUFACTURE DATE: 21-AUG-2023 D4. MEDICAL DEVICE LOT #: 3201947 D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H4. DEVICE MANUFACTURE DATE: 21-AUG-2023 D4. MEDICAL DEVICE LOT #: 3201950 D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025 H4. DEVICE MANUFACTURE DATE: 21-AUG-2023 D4. MEDICAL DEVICE LOT #: 3305463 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025 H4. DEVICE MANUFACTURE DATE: 01-NOV-2023. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR LOW YIELD WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM EACH LOT OF BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO LOW YIELD AS ALL SAMPLES MET SPECIFICATIONS. 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 LOW YIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE PAXGENE® BLOOD CCFDNA TUBE, THERE POOR YIELD OF CCFDNA DUE TO GENOMIC DNA CONTAMINATION. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES OVER THE PAST YEAR. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299656 PAXGENE® BLOOD CCFDNA TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H10 04053727681652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown