BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY HYPODERMIC NEEDLE REF-SG3

    MDR report key: 10747787 · Received October 27, 2020

    Report

    Report Number
    MW5097488
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 10, 2020
    Report Date
    October 23, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AFTER ADMINISTERING THE FLU INJECTION TO A PATIENT, THE MA CLOSED THE SAFETY CAP ON THE NEEDLE AND THE NEEDLE BOWED OUT FROM THE CAP CAUSING A POTENTIAL FOR A FINGER POKE. THE MA NOTICED AND THE NEEDLE DID NOT CONTACT HER SKIN. THIS IS THE 2ND OCCURRENCE OF THIS TYPE OF MALFUNCTION. THE FIRST TIME RESULTED IN INJURY AND WAS REPORTED TO EMPLOYEE HEALTH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209382 SAFETY HYPODERMIC NEEDLE REF-SG3 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO MEDICAL CORPORATION REF-SG32525 200203C
    1209383 SAFETY HYPODERMIC NEEDLE REF-SG3 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR