FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 7FR X 30CM
MDR report key: 3823703
·
Received February 20, 2014
Report
- Report Number
- 3006425876-2014-00035
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- February 11, 2014
- Report Date
- February 11, 2014
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER INSERTION OR THE SELDINGER NEEDLE, THE USER NOTICED THAT THE "CONE" OF THE NEEDLE APPEARED TO BE CRACKED. THE USER NOTED THERE WERE SEVERAL VISIBLE CRACKS ON THE "CONE." THE USER ALSO STATED THAT THE CRACKS APPEARED WITHOUT ANY EFFORT. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW SET. IT IS UNKNOWN WHETHER THERE WAS A DELAY; HOWEVER THERE WAS NO REPORTED HARM, DEATH, OR COMPLICATION TO THE PATIENT AS A RESULT OF THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106676 | CVC KIT: 2-LUMEN 7FR X 30CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |