Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd. |
san diego CA 92121 |
|
MDR Report Key | 5572960 |
MDR Text Key | 42583995 |
Report Number | 5572960 |
Device Sequence Number | 1 |
Product Code |
FPA
|
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 |
03/25/2016,04/06/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 30204E |
Device Lot Number | 15115428 |
Other Device ID Number | H37030204E16 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/25/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/25/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/13/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 63 YR |
|
|