BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAM IO INTRAOSSEOUS ACCESS SYSTEM

    MDR report key: 19148833 · Received April 19, 2024

    Report

    Report Number
    3023316-2024-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 17, 2024
    Manufacturer
    SAM MEDICAL PRODUCTS
    Product Code
    FMI
    UDI-DI
    00822045000285
    PMA / PMN Number
    K191488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IT WAS DETERMINED THE MOST LIKELY CAUSE OF THE ISSUE IS AN OUT OF TOLERANCE CONDITION OF THE TAB WIDTH OF THE STYLET ADAPTOR AND/OR THE WIDTH OF THE SLOT OF THE STYLET ADAPTOR.

    Description of Event or Problem · 0

    A 27 Y/O MALE ENCOUNTERED A POTENTIALLY CRITICAL OCCURRENCE OF A CHRONIC CONDITION WHILE IN A EXTREMELY DIFFICULT LOCATION TO ACCESS BY FIRST RESPONDERS. THE PATIENT WAS EXTRICATED THEN MOVED TO AN AREA WHERE CARE COULD BE PROVIDED. ONCE CARE WAS STARTED A PARAMEDIC ATTEMPTED 3 PERIPHERAL IV'S WITHOUT SUCCESS AND THEN SUCCESSFULLY INSERTED A 25MM SAM IO NEEDLE SET IN LEFT PROXIMAL TIBIA. ONCE THE SAM IO NEEDLE SET WAS INSERTED THE PARAMEDIC WAS UNABLE TO SEPERATE THE STYLET FROM THE CANNULA SO THE IO NEEDLE SET WAS REMOVED RESULTING IN A POTENTIAL DELAY OF PATIENCE CARE. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE THE ED STAFF IMMEDIATELY ATTEMPTED PERIPHERAL VASCULAR ACCESS TWO ADDITIONAL TIMES WITHOUT SUCCESS. THE ED PHYSICIAN SIMUTANEOUSLY PREPARED THE PATIENT FOR CENTRAL VENOUS ACCESS WHICH WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081701 SAM IO INTRAOSSEOUS ACCESS SYSTEM INTRAOSSEOUS ACCESS SYSTEM CATHETER FMI SAM MEDICAL PRODUCTS SAM IO NEEDLE SET 25MM 25A220802A 00822045000285

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other