FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 7 FR X 30 CM
MDR report key: 3960127
·
Received June 23, 2014
Report
- Report Number
- 9680794-2014-00122
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 19, 2014
- Manufacturer
- ARROW INTERNACIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN WITHDRAWING THE SWG, THE SWG KINKED. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, NO DEATH OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364697 | CVC SET: 3-LUMEN 7 FR X 30 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNACIONAL INC. | CF2103473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |