Brand Name | CLEARLINK CONTINU-FLO SOLUTION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - CARTAGO |
see h10 |
see h10 |
cartago 30106 |
CS
30106
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 15693225 |
MDR Text Key | 305737056 |
Report Number | 1416980-2022-05822 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412048970 |
UDI-Public | (01)00085412048970 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K203609 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
11/29/2022 |
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 |
Other
|
Device Catalogue Number | 2C8537 |
Device Lot Number | R22F15031 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/03/2022 |
Initial Date FDA Received | 10/28/2022 |
Supplement Dates Manufacturer Received | 11/21/2022
|
Supplement Dates FDA Received | 11/29/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/17/2022 |
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 |
Treatment | PEMETREXED |