BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD RNA TUBE

    MDR report key: 16821048 · Received April 26, 2023

    Report

    Report Number
    9617032-2023-00493
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    NTW
    UDI-DI
    54053727621653
    PMA / PMN Number
    K082150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED AND NO ISSUES WERE OBSERVED; ALL WERE WITHIN SPECIFICATION. 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 HAS BEEN CONFIRMED FOR AN ADDITIVE ABNORMALITY. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION PERFORMED AND SINCE RETENTION SAMPLES AND DHR WERE ALL WITHIN SPECIFICATION. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ADDITION OF QSX+PK MIX TO PAXGENE® BLOOD RNA TUBE THE ADDITITVE TURNS A DARK GREY. PATIENT IMPACT HAS NOT YET BEEN REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT LIQUID TURNS DARK GREY AND MORE VISCOUS AFTER ADDITION OF QSX+PK MIX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206394 PAXGENE® BLOOD RNA TUBE RNA PREANALYTICAL SYSTEMS NTW BECTON, DICKINSON AND COMPANY (BD) 762165 0204817 54053727621653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown