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 60073
|
2242702068
|
|
MDR Report Key | 17298481 |
MDR Text Key | 319023273 |
Report Number | 1416980-2023-03468 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 00085412579412 |
UDI-Public | (01)00085412579412 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
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 |
08/15/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/11/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 2C2063K |
Device Lot Number | 23A003 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/07/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | FLUCLOXACILLIN (FLUBICLOX); SODIUM CHLORIDE |