FDA Adverse Event
Death
Summary report: N
MRI L/P PORT W/GROS 7.0F
MDR report key: 475803
·
Received July 31, 2003
Report
- Report Number
- 1720496-2003-00118
- Event Type
- Death
- Date Received
- July 31, 2003
- Date of Event
- March 27, 2003
- Report Date
- April 2, 2003
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CATHETER CAME OFF. THIS INCIDENT OCCURRED AFTER 8 DAYS AFTER PLACEMENT. THE DEVICE WAS PLACED UNDER FEMORAL VEIN. THE CATHETER WAS ALREADY RETRIEVED BY SNARE. THE PORT, CATHETER LOCK AND CATHETER (31.5 CM) WERE RETURNED. THE PATIENT PASSED AWAY A FEW DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRI L/P PORT W/GROS 7.0F | INTRAVASCULAR IMPLANTED | LJT | BARD ACCESS SYSTEMS | 0603873 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Death |