Brand Name | MERIT CUSTOM KIT |
Type of Device | INTRAVENOUS EXTENSION TUBING SET |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
south jordan, ut |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
|
south jordan, ut |
|
Manufacturer Contact |
david
lockridge
|
1600 merit parkway |
south jordan, ut
|
2084551
|
|
MDR Report Key | 9712684 |
MDR Text Key | 186549544 |
Report Number | 1721504-2020-00008 |
Device Sequence Number | 1 |
Product Code |
OJA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/20/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/14/2020 |
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 | K04-MZL6505 |
Device Lot Number | H1583957 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/30/2020 |
Date Manufacturer Received | 02/06/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/17/2019 |
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 |
|
|