FDA Adverse Event
Malfunction
Summary report: N
ARGON MEDICAL DEVICES
MDR report key: 3242797
·
Received July 17, 2013
Report
- Report Number
- MW5030976
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- July 17, 2013
- Report Date
- July 17, 2013
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PICC LINE CLOTTED PREMATURELY AND HAD TO BE REMOVED AND ANOTHER ONE PLACED. MEDICATION INFUSING AT TIME. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332687 | ARGON MEDICAL DEVICES | PICC LINE | LJS | ARGON MEDICAL DEVICES | 11042390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO |