Brand Name | DUO-VENT CLEARLINK LUER ACTIVATED VALVE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park d |
|
singapore 73875 0 |
SN
738750
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 12217325 |
MDR Text Key | 263150142 |
Report Number | 1416980-2021-04524 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412048956 |
UDI-Public | (01)00085412048956 |
Combination Product (y/n) | Y |
Reporter Country Code | CA |
PMA/PMN Number | K112893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
07/23/2021 |
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 |
Health Professional
|
Device Catalogue Number | 2C8419 |
Device Lot Number | SR20L13127 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/28/2021 |
Initial Date FDA Received | 07/23/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | INTRAVENOUS IMMUNOGLOBULIN; UNSPECIFIED PUMP |