Brand Name | PLEXITRON SOLUTION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - CALI |
calle 36 no. 2c-22 |
apartado aero 2446 |
cali NA |
CO
NA
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 15329256 |
MDR Text Key | 300405901 |
Report Number | 1416980-2022-04542 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412654621 |
UDI-Public | (01)00085412654621 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial,Followup |
Report Date |
10/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/31/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | MRC1012P |
Device Lot Number | SE22CB6 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/23/2022 |
Date Device Manufactured | 03/07/2022 |
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 |
|
|