FDA Adverse Event
Malfunction
Summary report: N
Q-SYTE
MDR report key: 18676023
·
Received February 9, 2024
Report
- Report Number
- 18676023
- Event Type
- Malfunction
- Date Received
- February 9, 2024
- Date of Event
- January 28, 2024
- Report Date
- January 29, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MD
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LEAKING OF Q SITE CONNECTED TO PICC LINE ON NEONATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1389362 | Q-SYTE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON, DICKINSON AND COMPANY | 385151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Female |