CUSTOM KIT
Received Jun 3, 2026 · Event occurred Feb 25, 2026
Report 1721504-2026-00098 · MDR key 25382649
Device
Generic name
Convenience Kit (multiple Products)
Manufacturer
Merit Medical Systems, Inc.Catalog number
K09-MS3216A
Lot number
H3411950
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. THE COMPLAINT IS CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED HOWEVER, IT IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THERE WAS CONTAMINATION IN THE FLUID PATHWAY. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.