MalfunctionDXT
BLUE DIAMOND¿
Received Aug 27, 2025 · Event occurred Aug 7, 2025
Report 1721504-2025-00324 · MDR key 22909983
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Merit Medical Systems Inc.Catalog number
IN7352/C
Lot number
H3143751
Product problems
- Unsealed Device Packaging
- Manufacturing, Packaging or Shipping Problem
- Packaging Problem
- Unsealed Device Packaging
- Manufacturing, Packaging or Shipping Problem
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THE INNER COMPONENTS OF THE PACKAGING WERE ENTRAPPED WITHIN THE SEAL OF THE OUTER PACKAGING.