CUSTOM KIT
Received Mar 24, 2026 · Event occurred Jan 27, 2026
Report 1721504-2026-00937 · MDR key 24676398
Device
Generic name
Basic Intravenous Administration Set
Manufacturer
Merit Medical Systems, Inc.Catalog number
K08-YP042
Lot number
H3290227
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS FOUND TO CONTAIN SALINE SOLUTION AS REPORTED. INSPECTION OF THE CLEAR TUBING FOUND A FREE-FLOATING OBJECT WITHIN THE SALINE IN THE TUBE. THIS OBJECT WAS INSPECTED UNDER MAGNIFICATION AND COMPARED TO A TAPPI CHART WHERE IT WAS FOUND TO BE LARGER THAN 0.20MM^2 WHICH IS UNACCEPTABLE. THE REPORTED FAILURE CAN BE CONFIRMED; HOWEVER, THE ROOT CAUSE OF THIS DEFECT IS UNABLE TO BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND ONE SIMILAR COMPLAINT 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 PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.