FDA Adverse Event
Other
Summary report: N
BARD ACCESS SYSTEM
MDR report key: 746353
·
Received September 23, 2005
Report
- Report Number
- MW1036711
- Event Type
- Other
- Date Received
- September 23, 2005
- Date of Event
- September 13, 2005
- Report Date
- September 23, 2005
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- Voluntary report
Narratives
Description of Event or Problem · 1
DURING THE INSERTION OF AN IMPLANTABLE INFUSION PORT, WHILE THE CATHETER WAS BEING GUIDED OVER THE RESERVOIR, THE DISTAL TIP OF THE CATHETER DEVELOPED A HOLE. THE PHYSICIAN WAS USING A DEBAKEY VASCULAR CLAMP TO GENTLY GUIDE THE CATHETER. WHEN RESISTANCE WAS MET, THE CATHETER WAS PULLED BACK AND EXAMINED. A SPLIT ALONG THE WALL 203 MM PROXIMAL TO THE END WAS IDENTIFIED. THE TIP OF THE CATHETER WAS CUT OFF AND CATHETER INSERTION COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD ACCESS SYSTEM | IMPLANTABLE INFUSION PORT | LJT | BARD ACCESS SYSTEMS | UNK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |