FDA Adverse Event
Malfunction
Summary report: N
CVS SET: 3-LUMEN 7FR X 20 CM
MDR report key: 3972883
·
Received April 28, 2014
Report
- Report Number
- 3006425876-2014-00092
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 23, 2014
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO. (B)(4).
Description of Event or Problem · 1
THIS IS THE SECOND ISSUE INVOLVING THIS PT, SEE MDR 3006425876-2014-00091 FOR THE FIRST COMPLAINT. DURING INSERTION IN THE ICU, THE CHIEF NURSE WAS UNABLE TO SUCCESSFULLY INSERT THE SECOND SWG/CATHETER RESULTING IN THE KINKING OF THE SWG. A THIRD KIT WAS OPENED AND USED WITHOUT. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO REPORTED DEATH OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253712 | CVS SET: 3-LUMEN 7FR X 20 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |