ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Apr 2, 2026 · Event occurred Mar 1, 2026
Report 3006425876-2026-00371 · MDR key 24765324
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Lot number
71F25J1404
Product problems
- Obstruction of Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
IT WAS REPORTED THAT: "ON (B)(6) 2026, IN THE HEMODIALYSIS UNIT, INSUFFICIENT BLOOD FLOW OCCURRED WITHIN LESS THAN TWO WEEKS AFTER CATHETER INSERTION." THERE WAS NO REPORTED PATIENT HARM. A NEW DEVICE WAS INSERTED SUCCESSFULLY.
Description of Event or Problem
IT WAS REPORTED THAT: "(B)(6) 2026, IN THE HEMODIALYSIS UNIT, INSUFFICIENT BLOOD FLOW OCCURRED WITHIN LESS THAN TWO WEEKS AFTER CATHE TER INSERTION." THERE WAS NO REPORTED PATIENT HARM. A NEW DEVICE WAS INSERTED SUCCESSFULLY.
Additional Manufacturer Narrative
(B)(4). THE REPORT OF A BLOCKED CATHETER WAS NOT CONFIRMED THROUGH ANALYSIS OF THE RETURNED REPRESENTATIVE SAMPLE. THE RETURNED REPRESENTATIVE SAMPLE MET ALL RELEVANT VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT THE ACTUAL CATHETER RETURNED FOR ANALYSIS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.