FDA Adverse Event
Summary report: N
RADIAL ARTERY CATHETERIZATION KIT
MDR report key: 1925913
·
Received December 8, 2010
Report
- Report Number
- 1925913
- Date Received
- December 8, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 8, 2010
- Manufacturer
- ARROW INTERNATIONAL ,INC.
- Product Code
- DQY
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
STAFF REPORT THAT THE PRODUCT COMES WITH A BRIDGE THAT CAN BE PLACED ACCROSS THE ARTERIAL CATHETER FOR SUTURING THE ARTERIAL LINE IN PLACE, BUT THEY DO NOT SUPPLY THE SUTURES. MANY TIMES IF THE ARTERIAL LINE IS NOT SUTURED IN PLACE, IT FALLS OUT VERY EASILY. OTHER MANUFACTURERS SUPPLY SUTURES AND EVEN SUTURE HOLDERS, BUT THIS MANUFACTURER DOES NOT. STAFF FEEL IF THE PRODUCT HAD SUTURES INCLUDED THEN THE MDS WOULD BE MORE LIKELY TO USE THEM WHICH WOULD DECREASE THE FREQUENCY OF ARTERIAL LINES FALLING OUT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PROVIDE SUTURES WITH THE PRODUCT WHICH WOULD ENCOURAGE PROVIDERS TO USE THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIAL ARTERY CATHETERIZATION KIT | ARTERIAL LINE | DQY | ARROW INTERNATIONAL ,INC. | REF AK-04020 | RF 0047668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |