MalfunctionOFL
ARROW MULTI-LUMEN/PSI KIT
Received May 26, 2026 · Event occurred Apr 28, 2026
Report 9680794-2026-00420 · MDR key 25285538
Device
Generic name
Introducer Catheter
Manufacturer
Arrow International LlcCatalog number
CA-11142
Lot number
33F25M0699
Product problems
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING INITIAL INSERTION OF THE MULTI-LUMEN CATHETER (MAC) THE INTRODUCER NEEDLE HUB WAS CRACKED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE" AND NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.