BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE COMFORT INS SYR 0.3ML DISP SYRIN 31G5

    MDR report key: 9383715 · Received November 26, 2019

    Report

    Report Number
    MW5091328
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMI
    UDI-DI
    86227065035
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH PT REGARDING HIS PREFERENCE TO RECEIVE BD SYRINGES RATHER THAN THE SURECOMFORT SYRINGES. HE STATED THAT THE SURECOMFORT SYRINGES HE HAD RECEIVED WERE MORE DULL AND ALSO SOME OF THEM HAD IRREGULAR SHAPE OR BARB ON THEM THAT WOULD CUT HIS SKIN UPON INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174701 SURE COMFORT INS SYR 0.3ML DISP SYRIN 31G5 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ALLISON MEDICAL, INC. 86227065035

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR