FDA Adverse Event
Malfunction
Summary report: N
ARTERIAL CATH SET: 20GA X 8CM
MDR report key: 4212790
·
Received August 4, 2014
Report
- Report Number
- 3006425876-2014-00165
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Date of Event
- April 20, 2014
- Report Date
- July 22, 2014
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQX
- PMA / PMN Number
- K810675
- 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 THE FOLLOWING INCIDENT OCCURRED IN THE RECOVERY SURGERY UNIT: A FEW DAYS AFTER THIS TYPE OF CATHETER WAS IN PLACE, THE WAVEFORM TURNED INTO A FLAT LINE AND STOPPED GIVING INSTANT READING OF THE PT'S BP. FURTHERMORE IT WAS DIFFICULT TO TAKE BLOOD SAMPLES FOR HEMOGLYCOTESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 455221 | ARTERIAL CATH SET: 20GA X 8CM | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTERNATIONAL INC | 71F14A1191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |