FDA Adverse Event
Malfunction
Summary report: N
HUMMI MICRO DRAW TRANSFER DEVICE
MDR report key: 9745208
·
Received February 24, 2020
Report
- Report Number
- 9745208
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Date of Event
- December 1, 2019
- Report Date
- January 6, 2020
- Manufacturer
- HUMMINGBIRD MED DEVICES INC
- Product Code
- KST
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
HUMMI MICRO-DRAW BLOOD TRANSFER DEVICE USED TO OBTAIN BLOOD GAS REPORTED TO BE DEFECTIVE WITH LEAK/CRACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210339 | HUMMI MICRO DRAW TRANSFER DEVICE | SYSTEM, BLOOD COLLECTION | KST | HUMMINGBIRD MED DEVICES INC | 19129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 DA |