ARROW HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB
Received Nov 28, 2025 · Event occurred Nov 3, 2025
Report 9680794-2025-00997 · MDR key 23670771
Device
Generic name
Catheter, Hemodialysis, Non-i
Manufacturer
Arrow International LlcCatalog number
CDC-25142-X1A
Lot number
36F25B0018
Product problems
- Component Missing
- Component Missing
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE REPORT OF A BLUNT DILATOR TIP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE DILATOR AND LIDSTOCK FOR ANALYSIS. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS BLUNT AND NOT TAPERED. FURTHER DIMENSIONAL ANALYSIS CONFIRMED THAT THE DILATOR LENGTH MEASURED BELOW SPECIFICATION. THE OUTER AND INNER DIAMETERS MEASURED WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND THE COMMENTS FROM MANUFACTURING, THE LIKELY ROOT CAUSE IS MANUFACTURING RELATED. FURTHER INVESTIGATION HAS BEEN INITIATED UNDER TELEFLEX QUALITY SYSTEMS TO EVALUATE THIS ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT "NO TIP ON DILATOR. TIP OF THE DILATOR WAS MISSING. PATIENT WAS NOT HARMED AND IN STABLE CONDITION."
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "NO TIP ON DILATOR. TIP OF THE DILATOR WAS MISSING. PATIENT WAS NOT HARMED AND IN STABLE CONDITION."