BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 16820003 · Received April 26, 2023

    Report

    Report Number
    9617032-2023-00487
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED 2 SAMPLES AND 7 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR SPLIT CAP AND WET UNIT LABEL WERE OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 100 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF SPLIT CAP AND WET UNIT LABEL WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE SPLIT CAP AND WET UNIT LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2020649. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. H.4. DEVICE MANUFACTURE DATE: 2022-01-20. D.4. MEDICAL DEVICE LOT #: 2111720. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. H.4. DEVICE MANUFACTURE DATE: 2022-04-21. H.3. 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 · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS A BROKEN LID/CAP AND SAMPLE LEAKAGE. THE LEAKAGE EVENT OCCURRED 2 TIMES. THE BROKEN DEVICE ISSUE OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT THE FOLLOWING TWO ISSUES. (1) LEAKAGE OF THE LIQUID WAS FOUND IN 2 TUBES IN A CARTON CONTAINING 100 TUBES. (2) A CAP WITH A LARGE SPLIT DOWN ITS SIDE WAS FOUND ON A TUBE IN A CARTON CONTAINING 100 TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS A BROKEN LID/CAP AND SAMPLE LEAKAGE. THE LEAKAGE EVENT OCCURRED 2 TIMES. THE BROKEN DEVICE ISSUE OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT THE FOLLOWING TWO ISSUES. LEAKAGE OF THE LIQUID WAS FOUND IN 2 TUBES IN A CARTON CONTAINING 100 TUBES. A CAP WITH A LARGE SPLIT DOWN ITS SIDE WAS FOUND ON A TUBE IN A CARTON CONTAINING 100 TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045547 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown