BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 12062708 · Received June 24, 2021

    Report

    Report Number
    3005798905-2021-03012
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 22, 2021
    Report Date
    June 26, 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

    DEVICE NOT RETURNED FOR TESTING. PRODUCTION RECORDS AND TREND ANALYSIS INVESTIGATED FOR LOT NUMBER 51131. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    THE END USER REPORTED TO THE DISTRIBUTOR THAT THE "BEVEL PULLS WHEN THE SYRINGE IS BEING REMOVED FROM THE ARM WHICH CAUSES EXTRA DAMAGE TO THE VEIN".

    Additional Manufacturer Narrative · 1

    PRODUCTION RECORDS AND TREND ANALYSIS INVESTIGATED FOR LOT NUMBER 51131. THE TESTING SHOWED NO INDICATION OF ABNORMALITIES OR MALFUNCTION AT TIME OF PRODUCTION.

    Description of Event or Problem · 1

    THE END USER REPORTED TO THE DISTRIBUTOR THAT THE "BEVEL PULLS WHEN THE SYRINGE IS BEING REMOVED FROM THE ARM WHICH CAUSES EXTRA DAMAGE TO THE VEIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958385 EASYTOUCH SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 51131

    Patients

    Seq Age Sex Outcome Treatment
    1