FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 3-LUMEN 7 FR (2.3 MM) X 12 (30
MDR report key: 3250150
·
Received July 24, 2013
Report
- Report Number
- 3006425876-2013-00126
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- June 22, 2013
- Report Date
- July 4, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE PT'S ROOM NINE DAYS AFTER THE PLACEMENT OF THE CATHETER, A LEAK WAS FOUND FROM THE DISTAL LINE APPROX 1 CM FROM THE EXTENSION LINE HUB. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347032 | CVC KIT: 3-LUMEN 7 FR (2.3 MM) X 12 (30 | ADULT MULTI-LUMEN CATHETER | DQY | ARROW INTERNATIONAL INC | ZF3026536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |