ACCESSPLUS¿
Received Mar 26, 2026 · Event occurred Aug 27, 2025
Report 1721504-2026-00946 · MDR key 24702389
Device
Generic name
Haemostasis Valve
Manufacturer
Merit Medical Systems, Inc.Catalog number
MAP152/CNF
Lot number
I3103011
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
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.