MalfunctionMJI
MARGINMARKER
Received Dec 2, 2024 · Event occurred Sep 19, 2024
Report 20818246 · MDR key 20818246
Device
Generic name
Specimen/tissue, Identification Orientation
Manufacturer
Vector Surgical, LlcCatalog number
MMS6
Lot number
MM102.0124 AND MM103.0324
Patient
62 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MARKER PAINT WAS DRY AND NOT WORKING AS IT'S SUPPOSE TO. THE PACKAGE WAS NOT FAULTY, NO BREAK IN STERILITY. SALINE WAS ADDED TO PAINT TO HELP MAKE THE PRODUCT FUNCTIONAL. MANUFACTURER RESPONSE FOR STERILE INK KIT, MARGINMARKER (PER SITE REPORTER). VENDOR FILED A FORMAL COMPLAINT AND ASSIGNED A RMA/CASE NUMBER. THEY REQUESTED SOME PRODUCT FROM THE SAME LOT TO BE RETURNED FOR INVESTIGATION.