BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 24749707 · Received March 31, 2026

    Report

    Report Number
    9617032-2026-00381
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    February 15, 2026
    Report Date
    April 7, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. RETURNED TO MANUFACTURER: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9. DEVICE AVAILABLE FOR EVAL? 09-MAR-2026. INVESTIGATION SUMMARY: BD HAD RECEIVED ONE SAMPLE FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED SAMPLE WAS PERFORMED, AND NO INSTANCES OF DAMAGED TUBES WERE FOUND. FURTHERMORE, A VISUAL INSPECTION WAS PERFORMED ON 100 RETAINED SAMPLES, AND NO INSTANCES OF DAMAGED TUBES WERE FOUND. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: CRACKED PRODUCT/COMPONENT. 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 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K082150. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED ON 100 RETAINED SAMPLES, AND NO INSTANCES OF DAMAGED TUBES WERE FOUND. 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 NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: DAMAGED. 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 WHILE USING PAXGENE® BLOOD RNA TUBE, ONE TUBE CRACKED AND BROKE DURING THE THAWING PROCESS, RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PAXGENE® BLOOD RNA TUBE, ONE TUBE CRACKED AND BROKE DURING THE THAWING PROCESS, RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470799 PAXGENE® BLOOD RNA TUBE SYSTEM, BLOOD COLLECTION, RNA STABILIZATION, RNA PURIFICATION, RT-PCR MOLECULAR NTW BECTON, DICKINSON AND COMPANY (BD) 4114042 04053727621658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown