MEDLINE
Received Jul 6, 2026 · Event occurred Jun 8, 2026
Report 1417592-2026-04477 · MDR key 25727237
Device
Product problems
- Complete Blockage
- Difficult to Flush
Patient
Unknown
- Discomfort
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT AN EPIDURAL CATHETER "FAILED DUE TO OCCLUSION." PER THE CUSTOMER, THERE WERE NO "EXTRINSIC COMPRESSION OR ISSUES WITH THE PUMPS." THE CUSTOMER STATED THAT THE CATHETER WAS REMOVED AND REPLACED. THE CUSTOMER REPORTED THAT AFTER THE DEVICE WAS REMOVED, THEY WERE UNABLE TO MANUALLY FLUSH THE CATHETER WITH SALINE. THE CUSTOMER SAID THE PATIENT "EXPERIENCED PAIN DUE TO THE MALFUNCTIONING CATHETER" AND WAS "SUBJECTED TO REPEAT EPIDURAL PROCEDURES AND THE ASSOCIATED RISKS." THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
IT WAS REPORTED THAT AN EPIDURAL CATHETER "FAILED DUE TO OCCLUSION." PER THE CUSTOMER, THERE WERE NO "EXTRINSIC COMPRESSION OR ISSUES WITH THE PUMPS." THE CUSTOMER STATED THAT THE CATHETER WAS REMOVED AND REPLACED. THE CUSTOMER REPORTED THAT AFTER THE DEVICE WAS REMOVED, THEY WERE UNABLE TO MANUALLY FLUSH THE CATHETER WITH SALINE. THE CUSTOMER SAID THE PATIENT "EXPERIENCED PAIN DUE TO THE MALFUNCTIONING CATHETER" AND WAS "SUBJECTED TO REPEAT EPIDURAL PROCEDURES AND THE ASSOCIATED RISKS."