FDA Adverse Event
Injury
Summary report: N
2PC VSYS/PRT/LOCKS, 4NDL LW PFL
MDR report key: 3415340
·
Received October 7, 2013
Report
- Report Number
- 1219930-2013-00852
- Event Type
- Injury
- Date Received
- October 7, 2013
- Date of Event
- September 13, 2013
- Report Date
- September 13, 2013
- Manufacturer
- COVIDIEN, FORMERLY UNITED STATES SURGICAL
- Product Code
- LJT
- PMA / PMN Number
- K952748
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: PORT CATHETER WAS BROKEN WHICH HAD BEEN IMPLANTED IN PT BODY ONE YEAR. CATHETER FELL INTO PT'S RIGHT ATRIUM AND WAS RETRIEVED WITH A CARDIAC CATHETER. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505817 | 2PC VSYS/PRT/LOCKS, 4NDL LW PFL | CHEMOSITE INFUSION PORT | LJT | COVIDIEN, FORMERLY UNITED STATES SURGICAL | N2J0053X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |