Brand Name | CLEO® 90 INFUSION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS HEALTHCARE MANUFACTURING |
s.a. de c.v. |
a d no.4 parque industrial int |
tijuana, b.c. 22425 |
MX
22425
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathal lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7027876 |
MDR Text Key | 91901131 |
Report Number | 3012307300-2017-02403 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042172 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/14/2017 |
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 |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/21/2017 |
Initial Date FDA Received | 11/14/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
|
|