PORTEX EPIDURAL CATHETER LATERAL EYES CLEAR
Received Jul 6, 2026 · Event occurred May 12, 2026
Report 3012307300-2026-07036 · MDR key 25725996
Device
Generic name
Catheter, Conduction, Anesthetic
Model number
100/382/116Catalog number
100/382/116CZ
Lot number
4383317
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING PATIENT USE, THE EPIDURAL CATHETER INSERTION RESISTANCE WAS ENCOUNTERED, PREVENTING FURTHER ADVANCEMENT. WHEN THE CATHETER WAS WITHDRAWN FOR REPOSITIONING OR REPLACEMENT, IT FRACTURED, LEAVING A SMALL FRAGMENT THAT WAS SUSPECTED TO REMAIN WITHIN THE EPIDURAL SPACE. THERE WERE A PATIENT INVOLVEMENT AND HARM WERE REPORTED.