FDA Adverse Event
Death
Summary report: N
BD POWERPICC SOLO 2 5FR TRIPLE LUMEN (WIRE)
MDR report key: 9763520
·
Received February 26, 2020
Report
- Report Number
- MW5093307
- Event Type
- Death
- Date Received
- February 26, 2020
- Date of Event
- February 14, 2020
- Report Date
- February 24, 2020
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RETAINED WIRE DISCOVERED ON POST-PROCEDURE X-RAY INSIDE PT'S RIGHT VENTRICLE. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222628 | BD POWERPICC SOLO 2 5FR TRIPLE LUMEN (WIRE) | CATHETER, INTRAVASCULAR, THERAPEUTIC LONG-TERM GREATER THAN 30 DAYS | LJS | BARD ACCESS SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 360 YR | Death| S |