FDA Adverse Event
Malfunction
Summary report: N
SPLIT SEPTUM MICRO T-CONNECTOR
MDR report key: 10919285
·
Received November 30, 2020
Report
- Report Number
- 10919285
- Event Type
- Malfunction
- Date Received
- November 30, 2020
- Date of Event
- November 15, 2020
- Report Date
- November 19, 2020
- Manufacturer
- HUMMINGBIRD MED DEVICES INC
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE HUMMI CRACKED AND LEAKED AT THE JUNCTION OF THE FLEXIBLE TUBING AND HARD PLASTIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1383638 | SPLIT SEPTUM MICRO T-CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | HUMMINGBIRD MED DEVICES INC | NMT8046 | 19293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 DA |