BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 1883560 · Received September 28, 2010

    Report

    Report Number
    1883560
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OB OBSTETRICS PATIENT ABOUT TO RECEIVE AN EPIDURAL PER THE ANESTHESIOLOGIST. MD ATTEMPTED TO INSERT THE EPIDURAL NEEDLE BUT FELT RESISTANCE. MD EVALUATED THE NEEDLE AND FOUND IT TO BE SOMEWHAT BLUNT AND NOT ABLE TO PENETRATE PATIENT'S SKIN. MD RETRIEVED ANOTHER NEEDLE AND FINISHED THE PROCEDURE. NO HARM/INJURY TO PATIENT AS SHE ALREADY HAD NUMBING MEDICATION APPLIED AND DID NOT FEEL THE FIRST NEEDLE ATTEMPT. NEEDLE WAS UNFORTUNATELY DISCARDED HOWEVER MANUFACTURER AND PRODUCT INFO WAS OBTAINED.======================HEALTH PROFESSIONAL'S IMPRESSION======================IT HAD A BLUNT TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL 19 GAUGE RF0089031

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR