Brand Name | PSI KIT: 8.5 FR |
Type of Device | INTERVENTIONAL PSI PRODUCTS |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL INC. |
312 commerce place |
|
asheboro NC 27203 |
|
Manufacturer Contact |
jamie
hartz
|
2400 bernville road |
reading, PA 19605
|
|
MDR Report Key | 6096278 |
MDR Text Key | 59720506 |
Report Number | 1036844-2016-00586 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K780532 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/20/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/11/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | AK-09803-CDC |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/20/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |