Brand Name | TUBE SET, STD VOL, STER |
Type of Device | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE CORPORATION |
see h10 |
see h10 |
see h10 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 13654260 |
MDR Text Key | 286469040 |
Report Number | 1416980-2022-00841 |
Device Sequence Number | 1 |
Product Code |
NEP
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
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 |
Report Date |
03/02/2022 |
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 | H93811 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/08/2022 |
Initial Date FDA Received | 03/02/2022 |
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 |
|
|