ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Feb 27, 2026 · Event occurred Feb 5, 2026
Report 3006425876-2026-00242 · MDR key 24466997
Device
Generic name
Catheter Subclavian
Manufacturer
Arrow International LlcCatalog number
CS-15122-F
Lot number
71F24G0066
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE REPORT OF A DAMAGED DILATOR BODY WAS CONFIRMED THROUGH THE COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE DILATOR FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE DILATOR BODY AND WITHIN THE DILATOR TIP. VISUAL INSPECTION IDENTIFIED A GRADUAL AND CONTINUOUS BEND ALONG THE DISTAL END OF THE DILATOR BODY. MICROSCOPIC EXAMINATION DID NOT IDENTIFY ANY WHITE STRESS MARKS ON THE DILATOR BODY. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED ON THE DILATOR BODY. DESPITE THE DAMAGE, THE DILATOR MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED "DURING USE" AND THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
IT WAS REPORTED THAT "DILATOR BENT DURING USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Description of Event or Problem
IT WAS REPORTED THAT "DILATOR BENT DURING USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Additional Manufacturer Narrative
(B)(4).