CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM
Received Mar 18, 2026 · Event occurred Feb 15, 2026
Report 3011237704-2026-00001 · MDR key 24631666
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Catalog number
100/491/718CZ
Lot number
4458922
Product problems
- Complete Blockage
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. THE DEVICE HISTORY REVIEW OF THE REPORTED LOT NUMBER FOUND NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.
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 IT WAS NECESSARY TO OPEN TWO DOUBLE-BLOCK KITS AS REQUESTED BY THE ANESTHESIOLOGIST, ACCORDING TO THE MEDICAL REPORT THE FIRST CATHETER HAD A BENT TIP, WHICH PREVENTED IT FROM ADVANCING THROUGH THE EPIDURAL SPACE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND THERE WAS NO HARM.