MERIT S-MAK¿
Received Jan 7, 2026 · Event occurred Sep 30, 2025
Report 1721504-2026-00795 · MDR key 23995571
Device
Generic name
Vascular Dilator, Single-use
Manufacturer
Merit Medical Systems, Inc.Catalog number
S-MAK401/C
Lot number
I3107599
Product problems
- Fracture
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE, FRACTURED NEEDLE, CAN BE OBSERVED; HOWEVER, DUE TO THE PRODUCT HAVING BEEN USED, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. 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.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT THE TIP OF THE NEEDLE BROKE. NO PATIENT INJURY.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.