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- Title
Epidural Conduction Device Fractures and Complications of Retained Fragments.
- Authors
Fischer, Robert
- Abstract
During the past 3 years, the US Food and Drug Administration (FDA) has received a growing number of adverse event reports on the breakage or fracturing and retention of anesthetic conduction device tips with associated complications. Serious injuries and other problems such as spinal stenosis, nerve root compression, and subcutaneous effusion can result. Several case reports demonstrate how the problems occur; some illustrate the severity of the problem. All cases are from adverse event reports in the FDA Center for Devices and Radiological Health (CDRH) Manufacturer and User Facility Device Experience database. Frequently, in the interest of not causing patient harm, a device fragment might not be removed as long as the patient is not neurologically compromised or at risk for infection or there is little potential for migration of the fragmented piece. On many occasions, the fragments remain in patients without their knowledge. The FDA wants to raise awareness of the problem and its potential impact in creating complications, encourage the practice of in forming patients of the fragmented device, and promote reporting of such incidents to CDRH via the Med Watch reporting system. Based on a search of the current literature, recommendations for prevention are suggested.
- Subjects
UNITED States; EPIDURAL anesthesia; CATHETERS; UNITED States. Food &; Drug Administration; ANESTHESIA; MEDICAL equipment
- Publication
AANA Journal, 2008, Vol 76, Issue 1, p37
- ISSN
0094-6354
- Publication type
Article