BASIXCOMPAK¿
Received May 20, 2025 · Event occurred Apr 28, 2025
Report 3011642792-2025-00092 · MDR key 22055293
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Merit Medical SystemsCatalog number
IN4802/K
Lot number
I3085679
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
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS LIKELY DUE TO A MISSING ADHESIVE APPLICATION, PERFORMED BY THE OPERATORS. 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.
Additional Manufacturer Narrative
THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT DURING USE THE INFLATION DEVICE FELL APART. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.