BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 24662044 · Received March 23, 2026

    Report

    Report Number
    9617032-2026-00309
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    September 4, 2025
    Report Date
    April 15, 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

    D2A, COMMON DEVICE NAME: SYSTEM, BLOOD COLLECTION, RNA STABILIZATION, RNA PURIFICATION, RT-PCR MOLECULAR. 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. 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. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. 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. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    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-APR-2026. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. VISUAL OBSERVATION OF THE RETURNED SAMPLE DID NOT SHOW ANY SIGNS OF THE REPORTED DEFECT OF CRACKING AT THE BOTTOM OF THE TUBE. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    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.

    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
    366767 PAXGENE® BLOOD RNA TUBE SEE H11 NTW BECTON, DICKINSON AND COMPANY (BD) 4114042 04053727621658

    Patients

    Seq Age Sex Outcome Treatment
    1