BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBES

    MDR report key: 20353008 · Received October 2, 2024

    Report

    Report Number
    9617032-2024-01591
    Event Type
    Malfunction
    Date Received
    October 2, 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: 19-SEP-2024 INVESTIGATION SUMMARY MATERIAL #: 761165 LOT/BATCH #: 4095154 BD RECEIVED 700 TOTAL SAMPLES (COMBINED SAMPLES FROM (B)(6)) AND 3 PHOTOS FOR INVESTIGATION. THE SAMPLES AND PHOTOS 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 300 TUBES HAD A TUBE LABEL BATCH NUMBER DIFFERENT TAN THE SHELF PACK LABEL. ADDITIONALLY THERE WERE A MIX OF TWO BATCH NUMBERS WITHIN TWO SHELF PACKS. THERE WERE NO HEALTH IMPACTS OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD DNA TUBES THAT 300 TUBES HAD A TUBE LABEL BATCH NUMBER DIFFERENT TAN THE SHELF PACK LABEL. ADDITIONALLY, THERE WERE A MIX OF TWO BATCH NUMBERS WITHIN TWO SHELF PACKS. THERE WERE NO HEALTH IMPACTS OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34184 PAXGENE® BLOOD DNA TUBES BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON AND COMPANY (BD) 4095154 04053727611659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown