BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH

    MDR report key: 14136904 · Received April 18, 2022

    Report

    Report Number
    3005798905-2022-03049
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 18, 2022
    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

    INITIAL TREND ANALYSIS FOR LOT 55062A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 55062A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    A RESERVED LOT TEST OF SYRINGE LOT NUMBER 55062A WAS CONDUCTED TO TEST THE CANNULA CLOGGING AND THE PLUNGER SLIP FUNCTION, BOTH TESTS RESULTED IN NO MALFUNCITON BEING FOUND. TO PREVENT A REOCCURING COMPLAINT OF BOTH THE CANNULA CLOGGING AND PLUNGER SLIPPING, TRAINING AND EDUCATION OF SYRINGE ASSEMBLY WORKERS WILL BE PROGRESSED.

    Description of Event or Problem · 0

    END-USER REPORTS THE INSULIN SYRINGE WITH LOT NUMBER 55062A IS NOT DRAWING THE INSULIN UP AND SOME OF THE SYRINGE PLUNGERS MUST BE USED WITH FORCE.

    Description of Event or Problem · 0

    END-USER REPORTS THE INSULIN SYRINGE WITH LOT NUMBER 55062A IS NOT DRAWING THE INSULIN UP AND SOME OF THE SYRINGE PLUNGERS MUST BE USED WITH FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626262 EASY TOUCH SYRINGE FMF MHC MEDICAL PRODUCTS, LLC 55062A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown