BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM IO INTRAOSSEOUS DEVICE

    MDR report key: 16792138 · Received April 21, 2023

    Report

    Report Number
    3023316-2023-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 21, 2023
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAM MEDICAL ATTEMPTED TO CONTACT THE REPORTING AGENCY/HEALTHCARE PROFESSIONAL IN SEVERAL FOLLOW-UP CALLS AND EMAILS BUT WAS UNABLE TO ESTABLISH CONTACT TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED ISSUE. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. NO DEVICE SPECIFIC INFORMATION WAS PROVIDED AND DHR REVIEW CANNOT BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED MALFUNCTION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER IN MEDWATCH REPORT (REPORT NUMBER: MW5115951): 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. SAM MEDICAL ATTEMPTED TO CONTACT THE REPORTING AGENCY/HEALTHCARE PROFESSIONAL IN SEVERAL FOLLOW-UP CALLS AND EMAILS BUT WAS UNABLE TO ESTABLISH CONTACT TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED ISSUE. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. NO DEVICE SPECIFIC INFORMATION WAS PROVIDED AND DHR REVIEW CANNOT BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED MALFUNCTION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521820 SAM IO INTRAOSSEOUS DEVICE SAM IO FMI SAM MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other