BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 20325468 · Received September 27, 2024

    Report

    Report Number
    9617032-2024-01562
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 27, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 18-SEP-2024. INVESTIGATION SUMMARY. MATERIAL #: 761165. LOT/BATCH #: 4095154. BD RECEIVED 700 TOTAL SAMPLES (COMBINED SAMPLES FROM (B)(4)) AND 1 PHOTO FOR INVESTIGATION. THE SAMPLES AND PHOTO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR INCORRECT LABEL INFORMATION WAS OBSERVED. EVALUATION OF BOTH 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.

    Additional Manufacturer Narrative · 0

    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 PRIOR TO USING PAXGENE® BLOOD DNA TUBES THAT TWO (2) SHELF PACK LABELS HAD A DIFFERENT BATCH NUMBER THAN THE TUBE LABELS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD DNA TUBES THAT TWO (2) SHELF PACK LABELS HAD A DIFFERENT BATCH NUMBER THAN THE TUBE LABELS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739824 PAXGENE® BLOOD DNA TUBE BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON AND COMPANY (BD) 4095154 04053727611659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown