FDA Adverse Event
Malfunction
Summary report: N
3-L CVC KIT: 7 FR X 20 CM
MDR report key: 3853618
·
Received April 3, 2014
Report
- Report Number
- 1036844-2014-00151
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- February 18, 2014
- Report Date
- March 11, 2014
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- FOZ
- PMA / PMN Number
- K993691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A KINKED SWG WAS REC'D ALONG WITH SAMPLES FOR TWO OTHER COMPLAINTS FROM THIS HOSPITAL. THE HOSPITAL WAS CONTACTED CONCERNING THE ADD'L UNRAVELED SWG THAT WAS REC'D BUT HAS BEEN UNABLE TO PROVIDE ANY INFO SURROUNDING THE DETAILS OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203087 | 3-L CVC KIT: 7 FR X 20 CM | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |