BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 19486976 · Received June 7, 2024

    Report

    Report Number
    3005798905-2024-03185
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 6, 2024
    Manufacturer
    FEEL TECH BIO CO., LTD.
    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 64235A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 64235A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    END USER REPORTS THAT IN 1 BOX OF 100 SYRINGES THAT APPROXIMATELY 20-30 EITHER DID NOT HAVE A CANNULA AT ALL, THE CANNULAS WERE LOOSE ON THE BARREL OR THE CANNULA WAS FOUND INSIDE OF THE CAP AFTER REMOVING. USER RECEIVED THE BOX FROM AMAZON IN GOOD CONDITION. ADDITIONALLY, WHEN THE USER UTILIZES THE SYRINGES THAT APPEAR TO BE IN GOOD CONDITION, THE MEDICATION WILL BUBBLE AND LEAK WHERE THE CANNULA MEETS THE BARREL. USER WAS STUCK WITH ONE CANNULA ON (B)(6) 2024 THAT APPEARED TO BE PROPERLY ADHERED TO THE BARREL BUT WAS STUCK BY THE NEEDLE WHEN IT BECAME DISLODGED FROM THE BARREL RESULTING IN A VISIT TO URGENT CARE ON (B)(6) 2024 WHEN HER HAND BECAME SWOLLEN. URGENT CARE DOCTOR COULD NOT FIND ANY REMAINING CANNULA IN THE HAND AT THE TIME BUT USER WAS GIVEN CEPHALEXIN FOR BACTERIAL INFECTION AND USER WAS DIAGNOSED WITH CELLULITIS. URGENT CARE DOCTOR URGED THE USER TO GO TO EMERGENCY ROOM IF THE SWELLING IN THE HAND DID NOT RELIEVE BY (B)(6) 2024. END USER WAS CONTACTED TO PROVIDE MORE INFORMATION REGARDING HOW THE CANNULA RESULTED IN STICKING HER PERSON. USER DESCRIBED THAT DURING THE INJECTION SETUP PROCESS THAT THEY BELIEVE THAT THE PRESSURE OF INSERTING THE SYRINGE INTO THE INSULIN VIAL CAUSED THE NEEDLE TO DEPLUG BECAUSE SUDDENLY THE CANNULA WAS STUCK TO THE CENTER OF THE HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259263 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD. 64235A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown