BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11774483 · Received May 4, 2021

    Report

    Report Number
    3005798905-2021-03006
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TREND ANALYSIS FOR LOT NUMBER 52314, NO OTHER COMPLAINTS WERE LOCATED. WHILE CONDUCTING PRODUCTION RECORDS ANALYSIS FOR LOT NUMBER 52314, NO ABNOMALITIES WERE FOUND DURING PRODUCT MANUFACTURING REGARDING THE DEAD SPACE IN THE SYRINGE BARREL.

    Description of Event or Problem · 0

    END USER IS HAVING DIFFICULTIES ASPIRATING AIR BUBBLES OUT OF THE SYRINGES BEFORE USE. USER BELIEVES HE IS HAVING THESE TROUBLES BECAUSE THE CANNULA IS NOT FLUSH WITH THE INSIDE OF THE BARREL OF THE SYRINGE AND THE USER EXPLAINED THAT THE CANNULA APPEARS TO BE 1MM OUT FURTHER FROM THE DEAD SPACE OF THE SYRINGE BEFORE THE MARKINGS ON THE SYRINGE BEGIN THAN HE IS USED TO SEEING.

    Additional Manufacturer Narrative · 1

    WHEN INITIAL TREND ANALYSIS WAS PERFORMED FOR LOT NUMBER 52314 NO OTHER COMPLAINTS WERE FOUND. FURTHER INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 1

    END USER IS HAVING DIFFICULTIES ASPIRATING AIR BUBBLES OUT OF THE SYRINGES BEFORE USE. USER BELIEVES HE IS HAVING THESE TROUBLES BECAUSE THE CANNULA IS NOT FLUSH WITH THE INSIDE OF THE BARREL OF THE SYRINGE AND THE USER EXPLAINED THAT THE CANNULA APPEARS TO BE 1MM OUT FURTHER FROM THE DEAD SPACE OF THE SYRINGE BEFORE THE MARKINGS ON THE SYRINGE BEGIN THAN HE IS USED TO SEEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670347 EASYTOUCH SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 52314

    Patients

    Seq Age Sex Outcome Treatment
    1