BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 14962324 · Received July 8, 2022

    Report

    Report Number
    9617032-2022-00630
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 13, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    UDI-DI
    54053727611654
    PMA / PMN Number
    K142821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL 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. BD WAS ABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE OF UNDERFILL BASED ON THE PHOTOGRAPHS PROVIDED, HOWEVER RETAINED SAMPLES TEST RESULTS WERE SATISFACTORY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PAXGENE® BLOOD DNA TUBE DRAW VOLUME IS VERY SHORT. THIS EVENT OCCURRED 7 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT FOR PRODUCT CAT NO 761165 THE DRAW VOLUME IS VERY SHORT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PAXGENE® BLOOD DNA TUBE DRAW VOLUME IS VERY SHORT. THIS EVENT OCCURRED 7 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ALLEGES THAT FOR PRODUCT CAT NO 761165 THE DRAW VOLUME IS VERY SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849212 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 761165 1167487 54053727611654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown