BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO

    MDR report key: 4619557 · Received March 11, 2015

    Report

    Report Number
    4619557
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 5, 2015
    Report Date
    March 11, 2015
    Manufacturer
    VIDACARE LLC
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A CARDIOPULMONARY ARREST. RN ATTEMPTED TO OBTAIN INRAOSSEUS (IO) ACCESS AFTER PERIPHERAL IV ACCESS WAS LOST. 1ST ATTEMPT WAS IN LEFT TIBIA. AFTER PLACEMENT, DR STATED THE IO WAS "TOO LATERAL" AND WAS NOT "STEADY". 1ST IO REMOVED AND A SECOND ATTEMPT WAS MADE BY ANOTHER PHYSICIAN IN LEFT TIBIA.AFTER PATIENT WAS STABILIZED IN ICU, RNS ATTEMPTED TO REMOVE IO. HOWEVER, THE HUB DETACHED WHILE ATTEMPTING TO REMOVE BY HAND. THE NEEDLE REMAINED LODGED IN THE BONE. RNS THEN ATTEMPTED TO UTILIZE HEMOSTATS TO REMOVE NEEDLE WITH NO SUCCESS. DEVICE REP, CONTACTED BY MANAGER AND INSTRUCTED TO REMOVE NEEDLE WITH PLIERS. WHILE ATTEMPTING REMOVE NEEDLE WITH PLIERS, PORTION OF NEEDLE BROKE OFF. REP WAS CONTACTED AGAIN AND CAME TO BEDSIDE TO ASSESS SITE. REP STATES THE NEEDLE IS IN CORTICAL BONE AND RECOMMENDED ORTHOPAEDIC PHYSICIANS FOR REMOVAL OF NEEDLE.======================MANUFACTURER RESPONSE FOR VIDACARE CORPORATION- EZ-IO 45MM 15 GAUGE NEEDLE AND STABILIZER KIT, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166671 EZ-IO NEEDLE, HYPODERMIC FMI VIDACARE LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R