BASIXCOMPAK¿
Received May 20, 2025 · Event occurred Apr 24, 2025
Report 3011642792-2025-00086 · MDR key 22055282
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Merit Medical SystemsCatalog number
IN4130/JPH
Lot number
I3098958
Product problems
- Mechanical Problem
- Device Dislodged or Dislocated
- Unintended Movement
- Mechanical Problem
- Device Dislodged or Dislocated
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ACCOUNT ALLEGES THAT UPON INFLATING AND DEFLATING THE STENOSIS WITHIN THE PATIENT WITH THE DEVICE, THE ENTIRE PLUNGER CAME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND 1 SIMILAR COMPLAINT FOR THIS LOT NUMBER WAS FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.