CUSTOM KIT
Received Apr 17, 2026 · Event occurred Jan 28, 2026
Report 1721504-2026-00016 · MDR key 24918213
Device
Generic name
Convenience Kit (multiple Products)
Manufacturer
Merit Medical Systems, Inc.Catalog number
K09-MS2880
Lot number
H3332995
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE HOLE IS THE PACKAGING WAS OBSERVED. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ORIGIN OF THE HOLE IN THE PACKAGING; IT COULD HAVE BEEN PRESENT SINCE RECEIPT OF THE MATERIAL FROM THE SUPPLIER, OR IT MAY HAVE OCCURRED DURING THE PACKAGING PROCESS, TRANSPORT, OR THE INSPECTIONS CONDUCTED BY THE END USER. 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 A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING INCOMING INSPECTION BY A DEVICE DISTRIBUTOR. NO PATIENT INTERACTION OR INJURY TO REPORT.