FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 2-LUMEN 7 FR X 24 (60 CM)
MDR report key: 3181632
·
Received June 14, 2013
Report
- Report Number
- 1036844-2013-00204
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 13, 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). FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THIS IS THE SECOND OCCURRENCE INVOLVING THIS PT. SEE MDR# 1036844-2013-00203 FOR THE FIRST EVENT. IT WAS REPORTED THAT IN THE PT'S ROOM 1-2 DAYS AFTER THE CATHETER WAS PLACED IN THE PT'S FEMORAL VEIN, A LEAK FROM THE INSERTION SITE WAS FOUND. AS THE LEAK WAS MINIMAL, IT WAS SMALL ENOUGH TO BE COVERED USING GAUZE AND DRESSING AND THE CATHETER REMAINED IN SITU 10 DAYS AFTER PLACEMENT BEFORE BEING REMOVED. 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 |
|---|---|---|---|---|---|---|---|
| 271780 | CVC KIT: 2-LUMEN 7 FR X 24 (60 CM) | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTL., INC. | RF2123273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |