BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11704352 · Received April 21, 2021

    Report

    Report Number
    9616066-2021-50789
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 22, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING LEAKING FLUID 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 VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2420-0007 BATCH/ LOT #: UNKNOWN LEAKED FLUID.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING LEAKING FLUID 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 VALID LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2420-0007. BATCH/ LOT #: UNKNOWN. LEAKED FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601094 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1