BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 20458107 · Received October 15, 2024

    Report

    Report Number
    9617032-2024-01653
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    UDI-DI
    04053727611659
    PMA / PMN Number
    K231469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 761165, LOT/BATCH #: 4095154. BD RECEIVED THREE (3) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR INCORRECT LABEL INFORMATION WAS OBSERVED. EVALUATION OF THE PHOTOS INDICATED THAT THE SHELF LABEL HAD A LOT NUMBER 4095154 WITH EXPIRY DATE 30TH OF APRIL 2025, AND TUBE LABELS OF LOT 4079048 WITH EXPIRY DATE 31ST OF MAY 2025. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND UPON COMPLETION THE INDICATED FAILURE MODE FOR INCORRECT LABEL INFORMATION WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, SOME PRODUCT REQUIREMENTS FOR LOT RELEASE WERE UNMET AND NOT DISCOVERED PRIOR TO RELEASE. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE INCORRECT LABEL INFORMATION. A GLOBAL HOLD HAS BEEN PLACED ON THIS BATCH NUMBER. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF INCORRECT LABEL INFORMATION THROUGH SITUATION ANALYSIS AND CORRECTIVE AND PREVENTIVE ACTIONS. 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 BEFORE USING THE PAXGENE® BLOOD DNA TUBE THERE WAS A BATCH NUMBER MISMATCH BETWEEN THE SHELF PACK LABEL AND THE TUBE LABEL. THE EVENT AFFECTED 800 TUBES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE PAXGENE® BLOOD DNA TUBE THERE WAS A BATCH NUMBER MISMATCH BETWEEN THE SHELF PACK LABEL AND THE TUBE LABEL. THE EVENT AFFECTED 800 TUBES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567935 PAXGENE® BLOOD DNA TUBE EVACUATED BLOOD COLLECTION TUBE IVD, ANTICOAGULANT/NUCLEIC ACID STABILIZER PJE BECTON, DICKINSON AND COMPANY (BD) 4095154 04053727611659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown