Brand Name | CVC SET: 2-LUMEN 7 FR X 20 CM |
Type of Device | ARROWG+ARD CATHETER PRODUCTS |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL CR, A.S. |
jamska 2359/47 |
|
zdar nad sazavou 591 0 1 |
EZ
591 01
|
|
Manufacturer Contact |
jamie
hartz
|
2400 bernville road |
reading, PA 19605
|
|
MDR Report Key | 5700993 |
MDR Text Key | 46621024 |
Report Number | 3006425876-2016-00160 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K900263 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/02/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2015 |
Device Catalogue Number | CS-27702-E |
Device Lot Number | 23F13K0162 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/02/2016 |
Initial Date FDA Received | 06/06/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/03/2013 |
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 |