FDA Adverse Event
Injury
Summary report: N
2PC VSYS W/9FR INTR KIT LW PFL
MDR report key: 4780223
·
Received May 19, 2015
Report
- Report Number
- 1219930-2015-00412
- Event Type
- Injury
- Date Received
- May 19, 2015
- Date of Event
- April 27, 2015
- Report Date
- May 13, 2015
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- LJS
- PMA / PMN Number
- K961856
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE CONNECTION BETWEEN CATHETER + PORT OUTLET WAS FRACTURED. THEN THE FREE CATHETER FLEW INTO THE BLOOD VESSEL. THE PATIENT WAS IN A EMERGENCY TO TAKE THE FREE CATHETER OUT. PATIENT WAS INVOLVED AND THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION REQUESTED FROM THE ACCOUNT BUT NOT YET RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324411 | 2PC VSYS W/9FR INTR KIT LW PFL | CATHETER INTRODUCER KIT | LJS | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 120021 | N4G0223X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |