FDA Adverse Event
Malfunction
Summary report: N
DUALCAP
MDR report key: 22149175
·
Received June 5, 2025
Report
- Report Number
- 22149175
- Event Type
- Malfunction
- Date Received
- June 5, 2025
- Date of Event
- May 20, 2025
- Report Date
- May 29, 2025
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- QBP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
NO HARM TO PATIENT. 3 DUALCAP NOTED WITHOUT FOAM INSERT. ALTERNATE CAPS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723958 | DUALCAP | CAP, DEVICE DISINFECTANT | QBP | MERIT MEDICAL SYSTEMS, INC. | AO11159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |