ARROW EPIDURAL CATHETERIZATION KIT NRFIT
Received Dec 3, 2025 · Event occurred Nov 10, 2025
Report 3006425876-2025-01122 · MDR key 23705580
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
Arrow International LlcCatalog number
ASK-05500-NRO
Lot number
UNKNOWN
Product problems
- Material Separation
- Material Split, Cut or Torn
- Material Separation
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "THE CATHETER WAS FOUND CUT DURING PLACEMENT IN THE ICU. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT OCCURRED."
Additional Manufacturer Narrative
(B)(4). THE REPORTED COMPLAINT OF THE CATHETER BEING FOUND CUT DURING USE CONFIRMED BASED UPON THE INVESTIGATION OF THE SAMPLE RECEIVED. THE CUSTOMER RETURNED TWO CATHETER PIECES THAT WERE SEPARATED AT THE EXTRUSION. NONE OF THE CATHETER APPEARED TO BE MISSING. AT THE POINT OF SEPARATION, THERE WAS VERY LITTLE, IF ANY STRETCHING OF THE EXTRUSION AND COIL WIRE AS IT APPEARED THE CATHETER MAY HAVE BEEN CUT. ALL EPIDURAL CATHETERS ARE 100% TESTED FOR LEAKS AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A POTENTIAL LOT NUMBER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. THE DAMAGE TO THE CATHETER 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: "THE CATHETER WAS FOUND CUT DURING PLACEMENT IN THE ICU. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT OCCURRED."