Brand Name | ARROW CVC SET: 14 GA X 8" (20 CM) |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
MDR Report Key | 10424701 |
MDR Text Key | 203476512 |
Report Number | 9680794-2020-00343 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
PMA/PMN Number | K781978 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other |
Type of Report
| Initial,Followup |
Report Date |
08/10/2020 |
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 |
No Information
|
Device Expiration Date | 10/31/2023 |
Device Catalogue Number | CV-50014-BZ |
Device Lot Number | 14F18K0462 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/10/2020 |
Initial Date FDA Received | 08/19/2020 |
Supplement Dates Manufacturer Received | 09/23/2020
|
Supplement Dates FDA Received | 09/23/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|