BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE SHORT PEN 31G X 8 MM

    MDR report key: 13026099 · Received December 16, 2021

    Report

    Report Number
    MW5106140
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ULTI MED, INC.
    Product Code
    FMI
    UDI-DI
    20357515095859
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USING ULTICARE SHORT PEN 31G X 8 MM. NEEDLE IS VERY FLEXIBLE AND HAVE SEVERAL ISSUES WITH IT INCLUDING THE NEEDLE BENDING AND PENETRATING THE SAFETY CAP WHEN BRING RECAPPED. ALSO HAVE ONE INSTANCE WHERE THE NEEDLE WAS APPARENTLY BEND BEFORE BEING CAPPED RESULTING IN THE NEEDLE BEING COLLAPSED INTO A SPAGHETTI BOWL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913581 ULTICARE SHORT PEN 31G X 8 MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ULTI MED, INC. 7210106 20357515095859
    1913582 ULTICARE SHORT PEN 31G X 8 MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ULTI MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male