FDA Adverse Event
Malfunction
Summary report: N
2PC VSYS W/9FR INTR KIT LW PFL
MDR report key: 4859847
·
Received June 22, 2015
Report
- Report Number
- 1219930-2015-00487
- Event Type
- Malfunction
- Date Received
- June 22, 2015
- Date of Event
- June 10, 2015
- Report Date
- June 11, 2015
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- LJS
- PMA / PMN Number
- K961856
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: IMPLANT. ACCORDING TO THE REPORTER: BEFORE TO PROCEED TO INSERT THE CATHETER INTO THE VENA WAS DETECTED THAT THE PLASTIC COVER OF THE GUIDE WAS BROKEN. THE PHYSICIAN USED ANOTHER DEVICE. PATIENT STABLE, WITHOUT COMPLICATIONS. NO TISSUE OR BLOOD LOSS. PROCEDURE TIME NOT EXTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403763 | 2PC VSYS W/9FR INTR KIT LW PFL | CATHETER INTRODUCER KIT | LJS | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 120021 | N4C0839X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |