Brand Name | CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
carretera sanchez km 18.5 |
parque industrial itabo, piisa |
haina, san cristobal 91000 |
DR
91000
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 15472141 |
MDR Text Key | 301123281 |
Report Number | 1416980-2022-05007 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412486512 |
UDI-Public | (01)00085412486512 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K203609 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/25/2022 |
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 Catalogue Number | UC8519 |
Device Lot Number | DR22E11031 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/29/2022 |
Initial Date FDA Received | 09/23/2022 |
Supplement Dates Manufacturer Received | 10/21/2022
|
Supplement Dates FDA Received | 10/25/2022
|
Date Device Manufactured | 05/12/2022 |
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 |
|
|