Brand Name | ALARIS, SMARTSITE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION 303, INC. |
10020 pacific mesa blvd |
san diego CA 92121 |
|
MDR Report Key | 12405327 |
MDR Text Key | 269306393 |
Report Number | 12405327 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial |
Report Date |
08/16/2021 |
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 Model Number | 30263E |
Device Catalogue Number | 30263E |
Device Lot Number | 20069051 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/16/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/01/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/01/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|