MalfunctionOFL
ARROW MULTI-LUMEN/PSI KIT
Received May 4, 2026 · Event occurred Apr 8, 2026
Report 9680794-2026-00333 · MDR key 25073708
Device
Generic name
Introducer Catheter
Manufacturer
Arrow International LlcCatalog number
CA-11142
Lot number
33F25M0699
Product problems
- Crack
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT LEAKAGE WAS OBSERVED AT THE NEEDLE HUB DURING PRODUCT PREPARATION, PRIOR TO PATIENT CONTACT. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW DEVICE WAS OPENED AND UTILIZED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
(B)(4).