FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 7 FR X 24 (60 CM)
MDR report key: 3181633
·
Received June 14, 2013
Report
- Report Number
- 1036844-2013-00203
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 11, 2013
- Report Date
- June 13, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE PT'S ROOM ONE WEEK AFTER THE CATHETER WAS PLACED IN THE PT'S FEMORAL VEIN, A LEAK FROM THE INSERTION SITE WAS FOUND. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED. SEE MDR # 1036844-2013-00204 FOR THE SECOND EVENT WITH THE SAME PT. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271014 | CVC KIT: 2-LUMEN 7 FR X 24 (60 CM) | MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF2123273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |