BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELI

    MDR report key: 8843466 · Received July 30, 2019

    Report

    Report Number
    1058382-2019-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 30, 2019
    Manufacturer
    GEMTIER MEDICAL (SHANGHAI) INC.
    Product Code
    FMI
    UDI-DI
    00386120008646
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION E3, 02/20/2020: UPDATED INITIAL REPORTER OCCUPATION TO "NON-MEDICAL PROFESSIONAL" MANUACTURER/IMPORTER NARRATIVE: SECTION H10; 02/20/2020: WE ARE MOVING TO CLOSE THIS COMPLAINT FILE BASED ON THE CORRECTIVE ACTION TAKEN BY THE FACTORY TO IMPROVE THE SHARPNESS OF THE CANNULA. SAMPLES OF THE IMPROVED PRODUCT WERE SENT TO A LARGE US CUSTOMER FOR FEEDBACK. AFTER A REASONABLE ATTEMPT TO GET DOCUMENTED FEEDBACK ON THE IMPROVED SAMPLES FROM THIS CUSTOMER, WE ARE ACCEPTING THE IMPROVEMENTS MADE BY THE FACTORY BASED ON THE PENETRATION FORCE AND COMPETITIVE SAMPLE TEST DATA COMPILED TO EVALUATE THE CHANGE. TESTING RESULTS OF THE IMPROVEMENTS MADE SHOW AN IMPROVEMENT IN PERFORMANCE AND ARE COMPARABLE WITH THE MARKET LEADER. WE CONSIDER THIS FILE CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DULL NEEDLE ON A BUTTERFLY CAUSED PAIN TO THE PATIENT BY MULTIPLE PHLEBOTOMISTS FROM ONE LAB CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DULL NEEDLE ON A BUTTERFLY CAUSED PAIN TO THE PATIENT BY MULTIPLE PHLEBOTOMISTS FROM ONE LAB CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637958 RELI SAFETY BLOOD COLLECTION SET FMI GEMTIER MEDICAL (SHANGHAI) INC. GSBCS23G-12 18BC001 00386120008646

    Patients

    Seq Age Sex Outcome Treatment
    1