FDA Adverse Event
Malfunction
Summary report: N
DUALCAP®
MDR report key: 22122345
·
Received June 2, 2025
Report
- Report Number
- 22122345
- Event Type
- Malfunction
- Date Received
- June 2, 2025
- Date of Event
- May 14, 2025
- Report Date
- May 16, 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. IT WAS DISCOVERED BY NURSING THAT THE CHG CENTRAL LINE CAPS WERE MISSING A SPONGE PIECE INSIDE OF THE CAP. WHEN THE CAPS WERE OPEN ONLY LIQUID CAME OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667270 | DUALCAP® | CAP, DEVICE DISINFECTANT | QBP | MERIT MEDICAL SYSTEMS, INC. | A011303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |