FDA Adverse Event
Injury
Summary report: N
IMPORT WITH USER-ATTACHABLE 9.5F BIOGLIDE CATHETER
MDR report key: 213155
·
Received March 5, 1999
Report
- Report Number
- 2021898-1999-00019
- Event Type
- Injury
- Date Received
- March 5, 1999
- Date of Event
- September 4, 1998
- Report Date
- November 30, 1998
- Manufacturer
- MEDTRONIC PS MEDICAL
- Product Code
- LJT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IMPORT IMPLANTED ON 07/23/98. REVISED ON 09/04/1998 DUE TO CATHETER FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPORT WITH USER-ATTACHABLE 9.5F BIOGLIDE CATHETER Implant | IMPLANTED PORTS AND CATHETERS FOR VENOUS INFUSION | LJT | MEDTRONIC PS MEDICAL | NA | L3496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |