MalfunctionOFL
ARROW MULTI-LUMEN/PSI KIT
Received Apr 8, 2026 · Event occurred Mar 16, 2026
Report 9680794-2026-00260 · MDR key 24815988
Device
Generic name
Introducer Catheter
Manufacturer
Arrow International LlcCatalog number
CA-11142
Lot number
33F25J1031
Product problems
- Leak/Splash
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 PUNCTURE NEEDLE IS LEAKING AT THE HUB, THEY OPENED 3 KITS FROM THE SAME LOT NUMBER AND HAD ALL THE SAME ISSUES. THE PATIENT WAS REPORTED AS FINE." ASSOCIATED COMPLAINT ., 9680794-2026-00259 AND 9680794-2026-00258.