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 MFG |
s.a. de c.v. ave calidad no. 4 |
parque industrial internaciona |
tijuana, 22425 |
MX
22425
|
|
Manufacturer Contact |
jennifer
meng
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833078
|
|
MDR Report Key | 6609208 |
MDR Text Key | 76559407 |
Report Number | 3012307300-2017-01155 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586028397 |
UDI-Public | 10610586028397 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K042172 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/25/2017 |
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? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 09/28/2021 |
Device Catalogue Number | 21-7230-24 |
Device Lot Number | 76X158 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/18/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/12/2017 |
Initial Date FDA Received | 06/02/2017 |
Supplement Dates Manufacturer Received | 06/27/2017
|
Supplement Dates FDA Received | 07/25/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/03/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|