FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 7 FR X 16 CM
MDR report key: 3913098
·
Received May 14, 2014
Report
- Report Number
- 3006425876-2014-00105
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 7, 2014
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED DURING THE INTRODUCTION OF THE GUIDE WIRE THROUGH THE NEEDLE, IT WAS IMPOSSIBLE TO INSERT IT AND THEN IT WAS DIFFICULT TO REMOVE IT. THE SWG AND NEEDLE WERE REMOVED TOGETHER AND A NEW INSERTION WAS SUCCESSFULLY PERFORMED. THE SWG WAS UNRAVELED. NO CONSEQUENCE OR INJURY REPORTED FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287893 | CVC SET: 2-LUMEN 7 FR X 16 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | 71F13J1597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |