BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE BLOOD RNA TUBE

    MDR report key: 11375941 · Received February 24, 2021

    Report

    Report Number
    9617032-2021-00186
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 17, 2021
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. COMMON DEVICE NAME: SYSTEM, BLOOD COLLECTION, RNA STABILIZATION, RNA PURIFICATION, RT-PCR MOLECULAR DIAGNOSTIC TEST. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0100516. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0266688. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2020-09-22. (B)(4). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR INCORRECT LABEL CONTENT WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, FIFTY (50) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO INCORRECT LABEL CONTENT AS ALL SAMPLES MET SPECIFICATIONS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL INFO IS NOT ABLE TO BE DISPLAYED WITH A PAXGENE® BLOOD RNA TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SCANNING THE QR CODE, THERE ARE NO BRACKETS IN THE NUMBER DISPLAYED (IN CONTRAST TO OTHER LOT#).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268215 PAXGENE BLOOD RNA TUBE SEE H.10 NTW BECTON, DICKINSON AND COMPANY (BD) 762165 SEE H.10 54053727621653

    Patients

    Seq Age Sex Outcome Treatment
    1