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 |
DR
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 7323681 |
MDR Text Key | 101956610 |
Report Number | 1416980-2018-01200 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
UDI-Device Identifier | 00085412046341 |
UDI-Public | (01)00085412046341 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K993120 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/13/2018 |
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 Expiration Date | 09/01/2022 |
Device Catalogue Number | 2C8750 |
Device Lot Number | DR17H31041 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/13/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/12/2018
|
Initial Date FDA Received | 03/08/2018 |
Supplement Dates Manufacturer Received | 03/22/2018
|
Supplement Dates FDA Received | 04/13/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/01/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |