Brand Name | CLEARLINK BLOOD RECIPIENT SET |
Type of Device | SET, BLOOD TRANSFUSION |
Manufacturer (Section D) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
haina, san cristobal |
|
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 | 8293790 |
MDR Text Key | 134742803 |
Report Number | 1416980-2019-00468 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
UDI-Device Identifier | 00085412046341 |
UDI-Public | (01)00085412046341 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Type of Report
| Initial |
Report Date |
01/31/2019 |
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? |
No
|
Device Operator |
No Information
|
Device Catalogue Number | 2C8750 |
Device Lot Number | ASKU |
Initial Date Manufacturer Received |
12/31/2018
|
Initial Date FDA Received | 01/31/2019 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|