LIDCO
Received Jul 2, 2026 · Event occurred May 29, 2026
Report 8020616-2026-00034 · MDR key 25696379
Device
Generic name
Catalog Kit (primary Device Kit)
Manufacturer
Merit Medical Singapore Pte Ltd.Catalog number
689852/JPB
Lot number
C3030703
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECTED DEVICE HAS BEEN RETURNED FOR EVALUATION. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE ATTRIBUTED TO SURFACE CONTAMINATION ON THE LUER LOCK OF THE SYRINGE, RESULTING TO POOR ADHESION OF THE 2 PARTS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE PRODUCT HISTORY REVIEW WAS ANALYZED, AND NO EXCEPTION DOCUMENTS WERE FOUND. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION AND ENGINEERING TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.
Description of Event or Problem
CUSTOMER REPORTED SUSPECTED LEAK (NOT A BLOOD LEAK). NO PATIENT INJURY.