Brand Name | CADD ADMINISTRATION SET- FLOW STOP |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC |
6000 nathan lane north |
minneapolis MN 55442 |
|
MDR Report Key | 9263193 |
MDR Text Key | 164515975 |
Report Number | 3012307300-2019-05154 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586027406 |
UDI-Public | 10610586027406 |
Combination Product (y/n) | N |
PMA/PMN Number | K040636 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Type of Report
| Initial,Followup |
Report Date |
11/01/2019 |
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 |
Health Professional
|
Device Expiration Date | 10/09/2023 |
Device Catalogue Number | 21-7359-24 |
Device Lot Number | 3712544 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/01/2019 |
Initial Date FDA Received | 10/31/2019 |
Supplement Dates Manufacturer Received | 10/01/2019
|
Supplement Dates FDA Received | 11/01/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|