Brand Name | INFUSOR |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
BAXTER HEALTHCARE - IRVINE |
17511 armstrong avenue |
bldg 3 |
irvine CA 92614 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - IRVINE |
17511 armstrong avenue |
bldg 3 |
irvine CA 92614 |
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 5667993 |
MDR Text Key | 45573861 |
Report Number | 1416980-2016-09439 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K071222 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/19/2016 |
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 |
No Information
|
Device Expiration Date | 02/01/2019 |
Device Catalogue Number | 2C1009KP |
Device Lot Number | 16B018 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/09/2016 |
Initial Date Manufacturer Received |
04/29/2016 |
Initial Date FDA Received | 05/19/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/08/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |