BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11797862 · Received May 10, 2021

    Report

    Report Number
    3005798905-2021-03007
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 7, 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

    PRODUCTION RECORDS FOR LOT NUMBER 52626 WERE INVESTIGATED AND NEEDLE OUTER DIAMETER SHOWED NO INDICATOR OF ABNORMALITIES OR MALFUNCTIONS. THE GRADATION LINES FOR LOT 52626 WERE ALSO INVESTIGATED AND NO MALFUNCTIONS SHOWED. THERE WERE NO ABNORMALITIES/MALFUNCTIONS FOUND AT TIME OF PRODUCTION.

    Description of Event or Problem · 0

    END USER REPORTS THAT THE CIRCUMFERENCE OF THE SYRINGE DOES NOT APPEAR TO BE CORRECT IN COMPARISON TO ANOTHER BRAND. THE USER ALSO REPORTS THAT THE GRADATION LINES ARE SLANTED LIGHTLY TO THE LEFT.

    Additional Manufacturer Narrative · 1

    PRODUCTION RECORDS FOR LOT NUMBER 52626 WERE INVESTIGATED AND NEEDLE OUTER DIAMETER SHOWED NO INDICATOR OF ABNORMALITIES OR MALFUNCTIONS. THE GRADATION LINES FOR LOT 52626 WERE ALSO INVESTIGATED AND NO MALFUNCTIONS SHOWED. THERE WERE NO ABNORMALITIES/MALFUNCTIONS FOUND AT TIME OF PRODUCTION.

    Description of Event or Problem · 1

    END USER REPORTS THAT THE CIRCUMFERENCE OF THE SYRINGE DOES NOT APPEAR TO BE CORRECT IN COMPARISON TO ANOTHER BRAND. THE USER ALSO REPORTS THAT THE GRADATION LINES ARE SLANTED LIGHTLY TO THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692502 EASYTOUCH SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 52626

    Patients

    Seq Age Sex Outcome Treatment
    1