MalfunctionPPO
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received Jun 8, 2026 · Event occurred May 12, 2026
Report 3006425876-2026-00595 · MDR key 25431688
Device
Generic name
Catheter Subclavian
Manufacturer
Arrow International LlcCatalog number
CS-15122-F
Lot number
71F24H1397
Product problems
- Unraveled Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE "DILATOR UNRAVELED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, ADVERSE HEALTH CONSEQUENCES, OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.