Brand Name | INFUSOR |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - IRVINE |
17511 armstrong avenue |
building 3 |
irvine CA 92614 |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 15588942 |
MDR Text Key | 301940790 |
Report Number | 1416980-2022-05459 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K071222 |
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 |
10/12/2022 |
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 | 2C1009KP |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/13/2022 |
Initial Date FDA Received | 10/12/2022 |
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 |
|
|