BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY TOUCH PEN NEEDLE 31G 3/16 INCH

    MDR report key: 2026725 · Received March 16, 2011

    Report

    Report Number
    MW5019862
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MHC MEDICAL PRODUCTS
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT: MHC MEDICAL PRODUCTS EASY TOUCH PEN NEEDLES 3/16" 31 GAUGE PEN NEEDLES LOT NUMBER: P1 0002 MFG 02/2010 EXP 01/2015 NDC/HRI# (B)(4). THE EASY TOUCH PEN NEEDLES AS DESCRIBED ABOVE ARE HAVING SERIOUS ISSUES RELATED TO THE SYRINGE TIPS. BASICALLY WHAT IS OCCURRING IS THAT WHEN IT IS FASTENED TO A INSULIN PEN, THE NEEDLE IS MOVING UP ALONG THE HUB THAT THE NEEDLE IS ATTACHED TO THUS CAUSING THE NEEDLE EITHER BECOME DE-TACHED FROM THE HUB OR MOVE SO FAR UP THE HUB THAT IT DOES NOT TOUCH THE PEN SYRINGE. I HAVE HAD THE PEN SYRINGE TIP BECOME DETACHED AND STAY IN MY ARM AND STOMACH WHEN TRYING TO INJECT INSULIN INTO MYSELF. THIS IS A SERIOUS FLAW THAT I HAVE NOT ENCOUNTERED PREVIOUSLY WITH THIS BRAND. I HAVE TRIED THESE SYRINGE TIPS ON MULTIPLE PEN SYRINGES AND FOUND THEM TO MALFUNCTION IN THE SAME WAY REGARDLESS OF WHETHER THE INSULIN PEN SYRINGE WAS BRAND NEW OR ALREADY BEING USED. DATES OF USE: 6 DAYS; (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY TOUCH PEN NEEDLE 31G 3/16 INCH EASY TOUCH PEN NEEDLE FMF MHC MEDICAL PRODUCTS P1-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability