BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20DP CKV 2SS 117-IN 20PK

    MDR report key: 12329091 · Received August 16, 2021

    Report

    Report Number
    9616066-2021-51798
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    November 5, 2020
    Report Date
    July 21, 2021
    Product Code
    FPA
    UDI-DI
    37613203012448
    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 COMPONENT DAMAGE 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 2420-0500 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 20DP CKV 2SS 117-IN 20PK WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A040101 - FRACTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222185 GEM V/NV 20DP CKV 2SS 117-IN 20PK INTRAVASCULAR ADMINISTRATION SET FPA 2420-0500 UNKNOWN 37613203012448

    Patients

    Seq Age Sex Outcome Treatment
    1