FDA Adverse Event
Injury
Summary report: N
BARD
MDR report key: 3170016
·
Received June 10, 2013
Report
- Report Number
- MW5030526
- Event Type
- Injury
- Date Received
- June 10, 2013
- Date of Event
- June 9, 2013
- Report Date
- June 10, 2013
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
(B)(6) FEMALE ADMITTED (B)(6) 2013 FOR SHORTNESS OF BREATH, COUGH AND FEVER. PICC LINE PLACED (B)(6) 2013 WITH BARD POWER PICC. CHEST RAY TO DOCUMENT PICC. CT SCAN (B)(6) 2013 DEMONSTRATED COILED HIGH DENSITY STRUCTURE IN MAIN PULMONARY ARTERY. WIRE REMOVED FROM MAIN PULMONARY ARTERY (B)(6) 2013, COATED WITH THROMBUS, PRESUMED TO BE BROKEN GUIDE WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261665 | BARD | POWER PICC | LJS | BARD ACCESS SYSTEMS | POWER PICC | REXB0651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |