Brand Name | IMPRESS PERIPHERAL CATHETER |
Type of Device | PERIPHERAL CATHETER |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
14646 kirby drive |
houston TX 77047 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
14646 kirby drive |
|
houston TX 77047 |
|
Manufacturer Contact |
katie
swenson cqe,cba,cqpa.
|
1600 merit parkway |
south jordan, UT 84095
|
8012531600
|
|
MDR Report Key | 8190097 |
MDR Text Key | 131173798 |
Report Number | 3010665433-2018-00077 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/03/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2021 |
Device Catalogue Number | 56538KA2 |
Device Lot Number | E1438642 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/07/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/03/2018
|
Initial Date FDA Received | 12/21/2018 |
Supplement Dates Manufacturer Received | 01/14/2019
|
Supplement Dates FDA Received | 01/25/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/19/2018 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|