FDA Adverse Event
Malfunction
Summary report: N
MEDICAL IMAGING SOLUTIONS INTL.
MDR report key: 25113195
·
Received May 7, 2026
Report
- Report Number
- 25113195
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- October 14, 2025
- Report Date
- April 17, 2026
- Manufacturer
- CHS USA INC.
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
DURING POWER INJECTION, WE NOTICED INJECTION HAD CEASED AND HEARD A SNAP. SYRINGE WAS COMPLETELY BROKEN AT THE BASE.
Description of Event or Problem · 0
DURING POWER INJECTION, WE NOTICED INJECTION HAD CEASED AND HEARD A SNAP. SYRINGE WAS COMPLETELY BROKEN AT THE BASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115735 | MEDICAL IMAGING SOLUTIONS INTL. | INJECTOR AND SYRINGE, ANGIOGRAPHIC | DXT | CHS USA INC. | 400109 | 208645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |