ARROW EPIDURAL CATHETERIZATION KIT NRFIT
Received Dec 4, 2025 · Event occurred Nov 11, 2025
Report 3006425876-2025-01131 · MDR key 23714094
Device
Generic name
Anesthesia Conduction Catheter
Manufacturer
Arrow International LlcCatalog number
TU-05500-NRO
Lot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Material Twisted/Bent
- Fluid/Blood Leak
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE REPORTED COMPLAINT OF THE CATHETER LEAKING WAS CONFIRMED BASED ON THE EVALUATION OF THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE SNAPLOCK ASSEMBLY NRFIT AND AN EPIDURAL CATHETER. DURING THE FUNCTIONAL INSPECTION, THE RETURNED EPIDURAL CATHETER WAS CONFIRMED TO LEAK FROM WHERE THE CATHETER WAS DAMAGED AT APPROXIMATELY 14.6CM FROM THE PROXIMAL END. ALL EPIDURAL CATHETERS ARE 100% TESTED FOR LEAKS AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON A POTENTIAL LOT NUMBER, AND NO FINDINGS WERE IDENTIFIED TO SUGGEST A MANUFACTURING RELATED ISSUE. THE LEAK WAS DETECTED DURING USE. THEREFORE, BASED ON THE TIME OF DISCOVERY AND THE CONDITION OF THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT; "WHEN THE PATIENT WAS TRANSFERRED FROM THE BED TO A WHEELCHAIR, THE CATHETER WAS FOUND KINKED AND LEAK OCCURRED FROM THAT PART. AS A RESULT, THE CATHETER WAS REMOVED. NO INJURY TO THE PATIENT OCCURRED."
Description of Event or Problem
IT WAS REPORTED THAT; "WHEN THE PATIENT WAS TRANSFERRED FROM THE BED TO A WHEELCHAIR, THE CATHETER WAS FOUND KINKED AND LEAK OCCURRED FROM THAT PART. AS A RESULT, THE CATHETER WAS REMOVED. NO INJURY TO THE PATIENT OCCURRED."
Additional Manufacturer Narrative
(B)(4).