BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION KIT

    MDR report key: 3915391 · Received May 28, 2014

    Report

    Report Number
    1036844-2014-00221
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE EPIDURAL CATHETER BROKE OFF INTO THE PATIENT DURING REMOVAL. IT LEFT APPROXIMATED 4 TO 5 CM OF THE CATHETER INSIDE THE PATIENT. THE CATHETER WAS PLACED AFTER A FAILED SPINAL ATTEMPT. THE CATHETER (EPIDURAL) WAS THREADED BETWEEN 12-13 CM AND 5.5 CM INTO THE EPIDURAL SPACE. SURGICAL PROCEDURE - HIP REPLACEMENT. THE ALLEGED INCIDENT OCCURRED AFTER THE PATIENT RECEIVED A HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314546 ARROW EPIDURAL CATHETERIZATION KIT CAZ ARROW INTL., INC. 23F14C0762

    Patients

    Seq Age Sex Outcome Treatment
    1