Brand Name | CLEO® 90 INFUSION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC |
1265 grey fox rd |
|
st. paul, MN 55112 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, MN 55442
|
7633833310
|
|
MDR Report Key | 7854889 |
MDR Text Key | 119503367 |
Report Number | 3012307300-2018-01612 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 30610586028339 |
UDI-Public | 30610586028339 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K042172 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/06/2018 |
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 | 08/28/2021 |
Device Catalogue Number | 21-7220-24 |
Device Lot Number | 76X135 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/29/2017 |
Initial Date FDA Received | 09/07/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/24/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|