BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 24300301 · Received February 9, 2026

    Report

    Report Number
    9617032-2026-00115
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 20, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9. RETURNED TO MANUFACTURER: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9. DEVICE AVAILABLE FOR EVAL?: 06-FEB-2026. INVESTIGATION SUMMARY: PHOTOS OF 7 CUSTOMER RETURNED SAMPLES WERE INCLUDED FOR THE INVESTIGATION. EVALUATION OF THE PHOTOS INDICATED A CRACK/SCRATCH ON EACH OF THE TUBE WALLS. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO TUBE DAMAGE WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DAMAGED TUBE. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. BASED ON THE LOW DEFECT RATE FOR THE BATCH IN QUESTION, NO ACTIONS ARE PLANNED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS. D.2.A COMMON DEVICE NAME: SYSTEM, BLOOD COLLECTION, RNA STABILIZATION, RNA PURIFICATION, RT-PCR MOLECULAR DIAGNOSTIC TEST. E.1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K082150. 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 RNA TUBE, SEVEN (7) TUBES WERE FOUND TO HAVE CRACKS IN THE TUBE WALL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING PAXGENE® BLOOD RNA TUBE, SEVEN (7) TUBES WERE FOUND TO HAVE CRACKS IN THE TUBE WALL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116626 PAXGENE® BLOOD RNA TUBE SEE H11 NTW BECTON, DICKINSON AND COMPANY (BD) 4261187 04053727621658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown