Brand Name | CLEARLINK CONTINU-FLO SOLUTION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE |
600 mts oeste de entrada |
cartago |
CS |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE |
600 mts oeste de entrada |
|
cartago |
CS
|
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 5502963 |
MDR Text Key | 40388987 |
Report Number | 1416980-2016-05298 |
Device Sequence Number | 1 |
Product Code |
FPA
|
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,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/15/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 11/30/2020 |
Device Catalogue Number | 2C8541 |
Device Lot Number | R15K30065 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/07/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2015 |
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 |