Brand Name | ARROW CVC SET: 2-LUMEN 8FR X 20CM |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
MDR Report Key | 7685455 |
MDR Text Key | 113909272 |
Report Number | 3006425876-2018-00448 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
06/29/2018 |
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 | 01/02/2020 |
Device Catalogue Number | CV-25802-E |
Device Lot Number | 71F18A2313 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/29/2018 |
Initial Date FDA Received | 07/13/2018 |
Supplement Dates Manufacturer Received | 07/18/2018
|
Supplement Dates FDA Received | 07/20/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|