MalfunctionMPB
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
Received May 19, 2026 · Event occurred Apr 21, 2026
Report 3006425876-2026-00542 · MDR key 25219508
Device
Generic name
Catheter Hemodialysis Non Impl
Manufacturer
Arrow International LlcCatalog number
CU-22122-F
Lot number
71F25H0283
Product problems
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, "FIBERS WERE FOUND INSIDE THE CATHETER." IT WAS REPORTED THAT THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT. THE DEVICE WAS NOT USED. THERE WERE NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT IMPACT OR INJURY ASSOCIATED WITH THIS EVENT.
Additional Manufacturer Narrative
(B)(4).