BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR UNKNOWN

    MDR report key: 4725973 · Received April 23, 2015

    Report

    Report Number
    3004526033-2015-00028
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PN # (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. OUR SALES REP OFFERED A RE-TRAINING REGARDING THIS ISSUE BUT WAS REJECTED DUE TO LACK OF TIME. OUR SALES REP FORWARDED THE IFU AND EZ-IO NEEDLE VISE TECHNIQUE CARD TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE COMPLETION OF THE PROCEDURE, THE PARAMEDIC ASSISTANT PRESSED THE NEEDLE INTO THE NEEDLE VISE AND IT STUCK THROUGH THE BOTTOM. THE ASSISTANT INJURED HIMSELF IN THE LEFT HAND. THE USUAL ACTIONS WERE TAKEN SUCH AS DOCUMENTATION, REPORTED TO MED DR ON DUTY, AND REPORTING TO ACCIDENT INSURANCE. THE PARAMEDIC WAS ALREADY TESTED FOR AN INFECTIOUS DISEASE BUT THE BLOOD SAMPLE EVAL IS STILL OUTSTANDING. IT WAS NOTED THAT THE PARAMEDIC ASSISTANT IS TRAINED ACCORDING TO THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270786 VASCULAR UNKNOWN VASCULAR UNKNOWN FMI VIDACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other