ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Jul 8, 2025 · Event occurred May 23, 2025
Report 3006425876-2025-00612 · MDR key 22436549
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Lot number
71F24E0590
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
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 "ON (B)(6) 2025, THE DOCTOR OPENED THE PACKAGE AND FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Description of Event or Problem
IT WAS REPORTED "(B)(6) 2025, THE DOCTOR OPENED THE PACKAGE AND FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
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. 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.