FDA Adverse Event
Malfunction
Summary report: N
LINE DRAW ARTERIAL BLOOD GAS KIT (ABG)
MDR report key: 618271
·
Received August 12, 2004
Report
- Report Number
- 1217052-2004-00064
- Event Type
- Malfunction
- Date Received
- August 12, 2004
- Date of Event
- July 1, 2004
- Report Date
- July 15, 2004
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- GJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER ALLEGES THE SYRINGE PLUNGER IS STICKING UPON EXPELLING AIR OR BLOOD. NO TREATMENT DUE TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINE DRAW ARTERIAL BLOOD GAS KIT (ABG) | TRAY BLOOD COLLECTION | GJE | SMITHS MEDICAL ASD, INC. | NA | K520437 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |