FDA Adverse Event
Death
Summary report: N
MRI CATHETER SUBCUTANEOUS PORT
MDR report key: 16552
·
Received June 6, 1994
Report
- Report Number
- 16552
- Event Type
- Death
- Date Received
- June 6, 1994
- Date of Event
- May 9, 1994
- Report Date
- May 28, 1994
- Manufacturer
- BARD ACCESS SYSTEM, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CATHETER BEING INSERTED IN OPERATING ROOM. PT SOON HAD PNEUMO/HEMOTHORAX FROM BLEEDING. EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRI CATHETER SUBCUTANEOUS PORT Implant | MRI CATHETER SUBCUTANEOUS PORT | LJT | BARD ACCESS SYSTEM, INC. | 36BE7344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |