BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PAXGENE® BLOOD TUBE

    MDR report key: 22204080 · Received June 13, 2025

    Report

    Report Number
    9617032-2025-01050
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B5. DESCRIBE EVENT: IT WAS REPORTED AFTER COLLECTION AND PROCESSING OF PAXGENE® BLOOD RNA TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED A GREYISH HUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. D1. MEDICAL DEVICE BRAND NAME: PAXGENE® BLOOD RNA TUBE. D2B. MEDICAL DEVICE TYPE: NTW. D4. MEDICAL DEVICE CATALOG #: 762165. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G4. PMA / 510(K)#: K082150. INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE EVALUATION OF THE PHOTO SHOWS POOR PLASMA IN THE TUBE. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: POOR SERUM/PLASMA. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER COLLECTION AND PROCESSING OF UNSPECIFIED BD PAXGENE® BLOOD TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED A GREYISH HUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER COLLECTION AND PROCESSING OF PAXGENE® BLOOD RNA TUBE, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED A GREYISH HUE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816204 UNSPECIFIED BD PAXGENE® BLOOD TUBE BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown