BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM IO

    MDR report key: 16610612 · Received March 23, 2023

    Report

    Report Number
    MW5115951
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 21, 2023
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CARDIAC ARREST, I ATTEMPTED TO UTILIZE THE SAM IO TO GAIN VASCULAR ACCESS ON A PATIENT ON HIS LEFT TIBIAL PLATEAU. THE PLACEMENT WAS CORRECT, AND THE PROPER SIZE IO WAS SELECTED. THE TROCHAR FAILED TO ENGAGE WITH THE BONE, AND BOTH MYSELF AND MY PARTNER WERE UNABLE TO SUCCESSFULLY INSERT THE IO. WE ULTIMATELY WERE FORCED TO USE THE BARIATRIC SIZE IN ORDER TO GET THE ITEM TO ENGAGE. I HAVE USED THE EZ IO PRODUCT MANY TIMES TO MUCH GREATER SUCCESS, AND WE ARE PULLING THE SAM IO'S FROM OUR UNITS. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522108 SAM IO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SAM MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other