Brand Name | ALARIS SYRINGE MODULE SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
Manufacturer (Section G) |
CAREFUSION |
10020 pacific mesa blvd |
|
san diego CA 92121 4386 |
|
Manufacturer Contact |
ade
ajibade
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 5937961 |
MDR Text Key | 54262961 |
Report Number | 9616066-2016-01202 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K811885 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/18/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 10014916 |
Device Catalogue Number | 10014916 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/22/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/18/2016 |
Initial Date FDA Received | 09/08/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 8110, 8015, MZ1000, TD |
Patient Outcome(s) |
Required Intervention;
|
|
|