inforMED
MalfunctionOGE

ARROW EPIDURAL CATHETERIZATION KIT NRFIT

Received Sep 10, 2025 · Event occurred Aug 18, 2025

Report 3006425876-2025-00833 · MDR key 23014294

Device

Generic name

Epidural Anesthesia Kit

Catalog number

ASK-05500-NRO

Lot number

71F24E0185

Product problems

  • Fluid/Blood Leak
  • Material Puncture/Hole
  • Fluid/Blood Leak
  • Material Puncture/Hole

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT: "THE MEDICAL AGENT WAS FOUND LEAKING FROM THE CATHETER DURING PLACEMENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT OCCURRED. CHECKING THE REMOVED CATHETER, A HOLE WAS FOUND AND IT SEEMED TO BE DAMAGED.".

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 FLAT FILTER NRFIT, ONE SNAPLOCK ASSEMBLY NRFIT, AND AN EPIDURAL CATHETER. THE RETURNED COMPONENTS WERE RECEIVED CONNECTED. MICROSCOPIC EXAMINATION OF THE CATHETER REVEALED THE CATHETER IS DAMAGED AT APPROXIMATELY 25.4CM (VIA CALIBRATED RULER) FROM THE DISTAL END. THE EXTRUSION APPEARS TO HAVE A CUT/HOLE. DURING THE FUNCTIONAL INSPECTION, THE RETURNED EPIDURAL CATHETER WAS CONFIRMED TO LEAK FROM WHERE THE CATHETER WAS DAMAGED AT APPROXIMATELY 25.4CM 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 THE EPIDURAL CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. THE LEAK WAS DETECTED DURING USE. THEREFORE, BASED ON THE TIME OF DISCOVERY AND THE CONDITION OF THE SAM PLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "THE MEDICAL AGENT WAS FOUND LEAKING FROM THE CATHETER DURING PLACEMENT. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT OCCURRED. CHECKING THE REMOVED CATHETER, A HOLE WAS FOUND AND IT SEEMED TO BE DAMAGED."