BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT TOUCH INSUIN PEN NEEDLES

    MDR report key: 11870001 · Received May 21, 2021

    Report

    Report Number
    MW5101500
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 20, 2021
    Report Date
    May 20, 2021
    Manufacturer
    JIANGSU CAINA TECHNOLOGY CO., LTD.
    Product Code
    FMI
    UDI-DI
    00850024759077
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CONFUSION ABOUT WRONG LABEL; (B)(4) ARE DISTRIBUTING UNAPPROVED SIZE 33G INSULIN PEN NEEDLES. A 510K DATA FOR SHOWS APPROVED ONLY FOR 29G, 30G, 31G, 32G. FDA 510K # IS K170846. POOR FLOW OF INSULIN DUE TO NEEDLE BEING THIN IS OBSTRUCTIVE AND NOT SUFFICIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761057 COMFORT TOUCH INSUIN PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI JIANGSU CAINA TECHNOLOGY CO., LTD. 33G, 6MM, 1/4 00850024759077
    761058 COMFORT TOUCH INSUIN PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI JIANGSU CAINA TECHNOLOGY CO., LTD. INSULIN PEN NEEDLES 00850024759053

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other