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. |
avenida calidad no. 4 |
parque industrial internaciona |
tijuana, baja california 22425 |
MX
22425
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7013518 |
MDR Text Key | 91452135 |
Report Number | 3012307300-2017-02376 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586028335 |
UDI-Public | 10610586028335 |
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 |
11/09/2017 |
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
|
Device Expiration Date | 04/19/2022 |
Device Catalogue Number | 21-7220-24 |
Device Lot Number | 77X056 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/26/2017 |
Initial Date FDA Received | 11/09/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/02/2017 |
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 | NOVOLOG |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 43 YR |
|
|