Brand Name | ARROW CVC SET: 2-LUMEN 7 FR X 20 CM |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
MDR Report Key | 7674527 |
MDR Text Key | 113622690 |
Report Number | 9680794-2018-00149 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
PMA/PMN Number | K862056 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Type of Report
| Initial,Followup |
Report Date |
06/26/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/10/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2022 |
Device Catalogue Number | CV-17702-E |
Device Lot Number | 14F17E0444 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 08/09/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|