FDA Adverse Event
Malfunction
Summary report: N
DUALCAP
MDR report key: 22001467
·
Received May 12, 2025
Report
- Report Number
- 22001467
- Event Type
- Malfunction
- Date Received
- May 12, 2025
- Date of Event
- May 7, 2025
- Report Date
- May 9, 2025
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- LKB
- 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. DUALCAP PORT PROTECTORS LOT# A011303, FOUND WITHOUT THE ALCOHOL FOAM, ONLY ALCOHOL NOTED INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392613 | DUALCAP | PAD, ALCOHOL, DEVICE DISINFECTANT | LKB | MERIT MEDICAL SYSTEMS, INC. | A011303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |