ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
Received Apr 14, 2026 · Event occurred Mar 17, 2026
Report 3006425876-2026-00486 · MDR key 24873523
Device
Generic name
Catehter Hemodialysis Non Impl
Manufacturer
Arrow International LlcCatalog number
CU-23122-F
Lot number
71F25K0275
Product problems
- Leak/Splash
- Material Deformation
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, THE SHAPE OF THE LUER HUB IS INCORRECT. CAUSING A LEAK. THE ISSUE WAS IDENTIFIED DURING USE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT HARM."
Additional Manufacturer Narrative
(B)(4). THE CUSTOMER REPORT OF A DAMAGED LUER HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE HEMODIALYSIS CATHETER FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE CATHETER BODY AND INSIDE BOTH EXTENSION LINES. FLATTENING WAS OBSERVED ON THE VENOUS LUER HUB. MANUFACTURING CONFIRMED THE OBSERVED DAMAGE WOULD HAVE PREVENTED THE CATHETER FROM PASSING REQUIRED 100% LEAK TESTING; THEREFORE, THE DAMAGE LIKELY OCCURRED POST-MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE RETURNED SAMPLE AND AVAILABLE INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "(B)(6) 2026, THE SHAPE OF THE LUER HUB IS INCORRECT. CAUDING A LEAK. THE ISSUE WAS IDENTIFIED DURING USE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT HARM."