Brand Name | CLEARLINK LUER ACTIVATED VALVE |
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 | 15857008 |
MDR Text Key | 306993606 |
Report Number | 1416980-2022-06457 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412656649 |
UDI-Public | (01)00085412656649 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/28/2022 |
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 | 2R8403 |
Device Lot Number | DR22E23024 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/01/2022
|
Initial Date FDA Received | 11/23/2022 |
Supplement Dates Manufacturer Received | 12/19/2022
|
Supplement Dates FDA Received | 12/28/2022
|
Date Device Manufactured | 05/24/2022 |
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 | CHEMOTHERAPY DRUG; CLEARLINK SYSTEM SOLUTION SET |
|
|