PORTEX NRFIT EPIDURAL CUSTOM KIT
Received Jun 22, 2026 · Event occurred May 29, 2026
Report 3012307300-2026-06313 · MDR key 25586691
Device
Generic name
Anesthesia Conduction Kit
Catalog number
24-1000-64
Lot number
6169728
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE NRFIT EPIDURAL FILTER DISCONNECTED FROM THE NRFIT EPIFUSE CATHETER CONNECTOR DURING INFUSION. THE DEVICE WAS REPLACED, AND NO FURTHER PROBLEMS WERE ENCOUNTERED. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED ADVERSE HARM. THE DISCONNECTION RESULTED IN A LEAK, WHICH COULD POTENTIALLY EXPOSE THE PATIENT AND/OR CLINICIAN TO MEDICATION IF THE ISSUE WERE TO RECUR.