BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 25056838 · Received May 1, 2026

    Report

    Report Number
    9617032-2026-00775
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 4, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    NTW
    UDI-DI
    04053727621658
    PMA / PMN Number
    DEN050003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B. COMMON DEVICE NAME: SYSTEM, BLOOD COLLECTION, RNA STABILIZATION, RNA PURIFICATION, RT-PCR MOLECULAR DIAGNOSTIC TEST. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K082150. E.1: INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY. INVESTIGATION SUMMARY: BD RECEIVED A PHOTO FOR INVESTIGATION. THE ATTACHED PHOTO SHOWS THE INDICATED FAILURE MODE OF FM INSIDE THE TUBE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: FOREIGN MATTER - NON-BIOLOGICAL. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTIONS ARE REQUIRED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING PAXGENE® BLOOD RNA TUBE, A FOREIGN OBJECT WAS FOUND INSIDE OF ONE TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63131 PAXGENE® BLOOD RNA TUBE SEE H.11 NTW BECTON DICKINSON & CO (FRANKLIN LAKES) 5021007 04053727621658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown