BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 15403152 · Received September 12, 2022

    Report

    Report Number
    9617032-2022-00853
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    K142821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATERIAL #: 761165. LOT/BATCH #: 1167487. BD RECEIVED 5 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 15 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 WHEN USING THE PAXGENE® BLOOD DNA TUBE ARE FILLING SLOW THUS RESULTING IN INSUFFICIENT FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER IS REPORTING BLOOD IS FILLING THE TUBE VERY SLOWLY WHEN USING PRODUCT 761165, LOT 1167487."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139321 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 1167487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown