BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO MEDICAL CORP.

    MDR report key: 6983173 · Received October 27, 2017

    Report

    Report Number
    MW5072978
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 12, 2017
    Manufacturer
    TERUMO (PHILIPPINES) CORP.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WENT TO ADMINISTER INJECTION TO PATIENT VIA THE IM ROUTE. USING THE REQUIRED AMOUNT OF FORCE ON THE PATIENT'S THIGH. THE NEEDLE DID NOT GO THROUGH THE SKIN AND INTO THE MUSCLE BELOW. I TRIED A SECOND TIME IN A DIFFERENT LOCATION WITH THE SAME RESULTS. I EXCUSED MYSELF FROM THE ROOM, REPLACED THE NEEDLE, AND GAVE THE INJECTION WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765094 TERUMO MEDICAL CORP. SURGUARD 3 (25G X 1") FMI TERUMO (PHILIPPINES) CORP. SG3-2525 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO