ARROW EPIDURAL CATHETERIZATION SET NRFIT
Received Dec 4, 2025 · Event occurred Nov 12, 2025
Report 3006425876-2025-01130 · MDR key 23713974
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
Arrow International LlcCatalog number
EJ-05400-NRO
Lot number
UNKNOWN
Product problems
- Material Split, Cut or Torn
- 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 TORN UNDER THE SNAPLOCK ADAPTER THE DAY AFTER PLACEMENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT OCCURRED."
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON POTENTIAL LOT BASED ON SALES HISTORY, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "THE CATHETER WAS FOUND TORN UNDER THE SNAPLOCK ADAPDER THE DAY AFTER PLACEMENT. THEREFORE, IT WAS REMOVED AND REPLACED WITH A NEW ONE. NO HARM TO THE PATIENT OCCURRED."