EPIDURAL CATHETERIZATION KIT NRFIT
Received Mar 26, 2026 · Event occurred Feb 18, 2026
Report 3006425876-2026-00325 · MDR key 24696736
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
Arrow International LlcCatalog number
ASK-05500-NRO
Lot number
71F25G0748
Product problems
- Migration or Expulsion of Device
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER DID PROVIDE A PHOTO THAT APPEARED TO SHOW A PIECE OF AN EPIDURAL CATHETER. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. CORRECTED DATA:
Description of Event or Problem
IT WAS REPORTED THAT: "THE CATHETER WAS FOUND TORN AND MIGRATED FROM THE PATIENT BODY DURING PLACEMENT. ACCORDING TO THE USER, HE/SHE DEALT WITH THE SITUATION APPROPRIATELY. NO HARM TO THE PATIENT OCCURRED.".
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "THE CATHETER WAS FOUND TORN AND MIGRATED FROM THE PATIENT BODY DURING PLACEMENT. ACCORDING TO THE USER, HE/SHE DEALT WITH THE SITUATION APPROPRIATELY. NO HARM TO THE PATIENT OCCURRED."