Brand Name | ALARIS EXTENSION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION 303, INC. |
120 s. state college, suite 100 |
brea CA 92821 |
|
MDR Report Key | 7230402 |
MDR Text Key | 98662794 |
Report Number | 7230402 |
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 |
Patient
|
Type of Report
| Initial |
Report Date |
01/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/31/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Nurse
|
Device Model Number | 10012866 |
Device Catalogue Number | 10012866 |
Other Device ID Number | EXTENSION SET 1.2 MICRON LOW |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/16/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/16/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | TUBING MAY HAVE BEEN Y'D WITH TPN OR FLUIDS MOST L |
Patient Weight | 2 |
|
|