FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 7 FR X 20 CM
MDR report key: 6080566
·
Received November 4, 2016
Report
- Report Number
- 3006425876-2016-00344
- Event Type
- Malfunction
- Date Received
- November 4, 2016
- Date of Event
- December 31, 2015
- Report Date
- November 4, 2016
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INSERTION IN ANE, THE MD WAS UNABLE TO ADVANCE THE GUIDE WIRE THROUGH THE INTRODUCER NEEDLE DUE TO SEVERE RESISTANCE. AS A RESULT, THE MD REMOVED THE GUIDE WIRE AND FOUND THE WIRE HAD KINKED. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729265 | CVC SET: 2-LUMEN 7 FR X 20 CM | ADULT MULTI LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. | 71F15C0338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |