BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DROPLET PEN NEEDLES 31G 8MM

    MDR report key: 15418630 · Received September 13, 2022

    Report

    Report Number
    MW5112010
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    September 9, 2022
    Report Date
    September 9, 2022
    Manufacturer
    HIGH TECH LAB /HTL-STREFA, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DROPLET PEN NEEDLES, NDC 08489-8309-10, ARE NOT SHARP ENOUGH TO PUNCTURE SKIN AND DELIVER INSULIN DOSES. THE PATIENT TRIED 10-15 NEEDLES AND THEY BENT EXTERNALLY INSTEAD OF GOING INTO HIS SKIN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621172 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621173 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621174 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621175 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621176 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC. B46ZE6
    2621177 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621178 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621179 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621180 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.
    2621181 DROPLET PEN NEEDLES 31G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HIGH TECH LAB /HTL-STREFA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention