BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW STIMUCATH SET: 19G CATH, 17G X 8CM NDL

    MDR report key: 4092567 · Received August 19, 2014

    Report

    Report Number
    1036844-2014-00340
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    OGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT IT IS DIFFICULT TO ADVANCE/REMOVE THE STYLET INTO THE CANNULA. THE CUSTOMER STATES THAT THERE IS SOME RESISTANCE IN THE AREA OF THE GRIP. NO REPORT OF PT INJURY/HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500215 ARROW STIMUCATH SET: 19G CATH, 17G X 8CM NDL NERVE BLOCK TRAY OGJ ARROW INTL., INC. 23F13G0669

    Patients

    Seq Age Sex Outcome Treatment
    1