BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 12334656 · Received August 17, 2021

    Report

    Report Number
    9616066-2021-51814
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    January 14, 2021
    Report Date
    July 21, 2021
    Product Code
    FPA
    UDI-DI
    37613203021020
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2420-0007 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED GEM V/NV 20D 1CV 2SS DEHP FREE HAD BACK FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A140501 - BACKFLOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231875 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA 2420-0007 UNKNOWN 37613203021020

    Patients

    Seq Age Sex Outcome Treatment
    1