Brand Name | CLEARLINK DUO-VENT SECONDARY MEDICATION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - CARTAGO |
see h10 |
|
cartago 30106 |
CS
30106
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 9781509 |
MDR Text Key | 181815912 |
Report Number | 1416980-2020-01145 |
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,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
04/02/2020 |
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 |
Other
|
Device Catalogue Number | 2H7462 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/12/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/06/2020 |
Initial Date FDA Received | 03/03/2020 |
Supplement Dates Manufacturer Received | 03/21/2020
|
Supplement Dates FDA Received | 04/02/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Treatment | 1000ML 0.9% SODIUM CHLORIDE; 1000ML VIAFLEX BAG; 5% 100ML IV MINI BAG; 5% DEXTROSE 100 ML; METHYLENE BLUE DYE; UNKNOWN ADMINISTRATIVE SET |