BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH INSULIN SYRINGE 31G-.3CC-5/16"

    MDR report key: 7586732 · Received June 11, 2018

    Report

    Report Number
    3005798905-2018-01998
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    March 9, 2017
    Report Date
    June 10, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY OBSERVED THAT "THERE WERE AIR BUBBLES IN THE SYRINGE". PRODUCT WAS RETURNED TO MEDLINE AND THEY "PUT WATER IN THE BARREL OF THE SYRINGE, AND NOTED AIR BUBBLES IN THE BARREL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431373 EASYTOUCH INSULIN SYRINGE 31G-.3CC-5/16" SYRINGE, PISTON FMF MHC MEDICAL PRODUCTS, LLC 831365 34285C

    Patients

    Seq Age Sex Outcome Treatment
    1