FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 2-L 7 FR X 8 (20 C
MDR report key: 3250242
·
Received July 24, 2013
Report
- Report Number
- 1036844-2013-00251
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- July 3, 2013
- Report Date
- July 16, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQY
- PMA / PMN Number
- K820648
- 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, A LEAK WAS FOUND FROM THE JUNCTION HUB OF THE CATHETER PLACED IN THE PT'S INTERNAL JUGULAR VEIN. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED ADN USED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE. THE PERIOD OF CATHETER PLACEMENT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346499 | MULTI-LUMEN CVC KIT: 2-L 7 FR X 8 (20 C | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RJ3026329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |