BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE BLOOD CCFDNA TUBE

    MDR report key: 12163354 · Received July 13, 2021

    Report

    Report Number
    9617032-2021-00763
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR TASK WILL BE CANCELLED PER DCHU BASED OFF OF MFG REPORT # 9617032-2021-00763 WITH DT 3232454.- SEE (B)(4) AS A DUPLICATE RECORD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED THE STOPPERS POPPING OFF OF THE TUBE AND CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: END USER REPORTED 3 OF 40 PAXGENE TUBES THAT LOST CAP DURING CENTRIFUGATION. THE STORAGE TEMPERATURE IS ACCORDING TO HB. YES, IT IS THE FIRST BATCH THAT WE HAVE DETECTED THAT THE TUBES BREAK. HOW MANY PREVIOUS PAXGENE TUBE KITS HAVE YOU SUCCESSFULLY USED? I GUESS KITS YOU MEAN BOXES, ABOUT 6 BOXES OF TUBES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD CCFDNA TUBE, THE DEVICE EXPERIENCED THE STOPPERS POPPING OFF OF THE TUBE AND CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: END USER REPORTED 3 OF 40 PAXGENE TUBES THAT LOST CAP DURING CENTRIFUGATION. THE STORAGE TEMPERATURE IS ACCORDING TO HB. YES, IT IS THE FIRST BATCH THAT WE HAVE DETECTED THAT THE TUBES BREAK. HOW MANY PREVIOUS PAXGENE TUBE KITS HAVE YOU SUCCESSFULLY USED? I GUESS KITS YOU MEAN BOXES, ABOUT 6 BOXES OF TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059496 PAXGENE BLOOD CCFDNA TUBE RNA PREANALYTICAL SYSTEMS JKA BECTON, DICKINSON AND COMPANY (BD) 0133849

    Patients

    Seq Age Sex Outcome Treatment
    1