FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 2-L 7 FR X 8IN (20 C
MDR report key: 2801073
·
Received October 17, 2012
Report
- Report Number
- 1036844-2012-00298
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 17, 2012
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K820648
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD¿L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE PTS ROOM ONE DAY AFTER THE CATHETER WAS PLACED IN THE (B)(6) FEMALE PT¿S FEMORAL VEIN, A LEAK FROM THE PROXIMAL EXTENSION WAS FOUND WHEN CHECKING FOR BACK FLOW OF BLOOD. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED W/O ISSUE. IT WAS NOTED THAT THE CATHETER WAS FLUSHED W/O ISSUE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN CVC KIT: 2-L 7 FR X 8IN (20 C | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | RF2019326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |