Brand Name | CADD® CADD® EXTENSION SETS |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7519953 |
MDR Text Key | 108493261 |
Report Number | 3012307300-2018-01764 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586023279 |
UDI-Public | 10610586023279 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K974013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/25/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/27/2022 |
Device Catalogue Number | 21-7106-24 |
Device Lot Number | 57X488 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/17/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/19/2018 |
Initial Date FDA Received | 05/16/2018 |
Supplement Dates Manufacturer Received | 08/30/2018
|
Supplement Dates FDA Received | 09/25/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/14/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|