Brand Name | ALARIS, SMART SITE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION 303, INC. |
10020 pacific mesa blvd. |
san diego CA 92121 |
|
MDR Report Key | 7605181 |
MDR Text Key | 111195499 |
Report Number | 7605181 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 37613203012448 |
UDI-Public | 37613203012448 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/05/2018 |
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 Model Number | 2420-0500 |
Device Catalogue Number | 2420-0500 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/05/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 06/05/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/15/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|