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 60073
|
2242702068
|
|
MDR Report Key | 9908042 |
MDR Text Key | 185900580 |
Report Number | 1416980-2020-01879 |
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 | K961225 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/05/2020 |
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 |
Health Professional
|
Device Catalogue Number | UC8519 |
Device Lot Number | DR20A20051 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/06/2020 |
Initial Date FDA Received | 03/31/2020 |
Supplement Dates Manufacturer Received | 04/22/2020
|
Supplement Dates FDA Received | 05/05/2020
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/21/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|