BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20D V/NV NTG .2MF 1SS DEHP FREE

    MDR report key: 12502671 · Received September 20, 2021

    Report

    Report Number
    9616066-2021-52094
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    July 28, 2021
    Report Date
    September 21, 2021
    Product Code
    FPA
    UDI-DI
    37613203015814
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THE FILTER BECAME SATURATED AND START LEAKING COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GEM 20D V/NV NTG .2MF 1SS DEHP FREE HAD FLOW ISSUES AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS RECEIVING IV CHEMOTHERAPY CONSISTING OF ETOPOSIDE, VINCRISTINE AND DOXORUBICIN PER EPOCH REGIMEN. IV FILTER IS BEING USED TO PREVENT PRECITATES FROM ETOPOSIDE FROM PASSING THROUGH. FILTER BECAME SATURATED AND CHEMOTHERAPY BEGAN LEAKING OUT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GEM 20D V/NV NTG .2MF 1SS DEHP FREE HAD FLOW ISSUES AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS RECEIVING IV CHEMOTHERAPY CONSISTING OF ETOPOSIDE, VINCRISTINE AND DOXORUBICIN PER EPOCH REGIMEN. IV FILTER IS BEING USED TO PREVENT PRECITATES FROM ETOPOSIDE FROM PASSING THROUGH. FILTER BECAME SATURATED AND CHEMOTHERAPY BEGAN LEAKING OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398884 GEM 20D V/NV NTG .2MF 1SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA 10010454 UNKNOWN 37613203015814

    Patients

    Seq Age Sex Outcome Treatment
    1