BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 3880330 · Received June 13, 2014

    Report

    Report Number
    MW5036647
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS CATHETER WAS INSPECTED BY CRNA PRIOR TO USE AND IT WAS NOTED THAT THE STYLET WAS FAULTY. CATHETER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349502 EPIDURAL CATHETERIZATION KIT EPIDURAL CATHETERIZATION KIT CAZ ARROW INTERNATIONAL REF WJ-05401 23F14B0391

    Patients

    Seq Age Sex Outcome Treatment
    1