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 | 10483233 |
MDR Text Key | 205317678 |
Report Number | 10483233 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10885403235276 |
UDI-Public | (01)10885403235276 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
08/13/2020,08/11/2020 |
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 |
Health Professional
|
Device Model Number | 37262E |
Device Catalogue Number | 37262E |
Device Lot Number | (10)200363 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/13/2020 |
Date Report to Manufacturer | 09/02/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/02/2020 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/02/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 28835 DA |
|
|