FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 8 FR X 16 CM
MDR report key: 4173785
·
Received August 7, 2014
Report
- Report Number
- 3006425876-2014-00169
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 28, 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
COMPLAINT NO. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INCIDENT TOOK PLACE IN THE DIGESTIVE SURGERY UNIT. IT WAS OBSERVED THAT THE "ATTACHMENT FIN AND CATHETER'S CENTRE SEPARATE. (DEFECT NOTICED ON A PATIENT)"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463728 | CVC SET: 2-LUMEN 8 FR X 16 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |