FDA Adverse Event
Injury
Summary report: N
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
MDR report key: 541166
·
Received August 25, 2004
Report
- Report Number
- 2183502-2004-00054
- Event Type
- Injury
- Date Received
- August 25, 2004
- Date of Event
- June 19, 2004
- Manufacturer
- SMITHS MEDICAL MD (FORMELY DELTEC,INC).
- Product Code
- MDV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER FRAGMENTED. THE PORTAL AND THE ATTACHED PORTION OF CATHETER WERE REMOVED. THE FRAGMENTED PORTION OF CATHETER WAS LEFT IN THE INTRATHECAL SPACE. A NEW SYSTEM WAS INSTALLED. THE PT IS RECEIVING PALLIATIVE CARE AT HOSPICE DUE TO ADVANCED CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM | EPIDURAL IMPLANTABLE ACCESS SYSTEM | MDV | SMITHS MEDICAL MD (FORMELY DELTEC,INC). | 21-1501 | 92329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |