Brand Name | CLEO® 90 INFUSION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS HEALTHCARE MFG |
s.a.dec.v. ave, calidad no. 4 |
parque industrial internaciona |
tijuana, bc 22425 |
MX 22425 |
|
Manufacturer (Section G) |
SMITHS HEALTHCARE MFG |
s.a.dec.v. ave, calidad no. 4 |
parque industrial internaciona |
tijuana, bc 22425 |
MX
22425
|
|
Manufacturer Contact |
lisa
perz
|
1265 grey fox road |
st paul 55112
|
7633833074
|
|
MDR Report Key | 5799852 |
MDR Text Key | 49735420 |
Report Number | 2183502-2016-01498 |
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 |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
06/20/2016 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 03/28/2021 |
Device Catalogue Number | 21-7220-24 |
Device Lot Number | 76X049 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/20/2016 |
Initial Date FDA Received | 07/15/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/21/2016 |
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 |
Patient Outcome(s) |
Other;
|
|
|