Brand Name | CADD |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
MDR Report Key | 11088066 |
MDR Text Key | 224152650 |
Report Number | 3012307300-2020-12807 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 15019517191820 |
UDI-Public | 15019517191820 |
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,foreig |
Type of Report
| Initial,Followup |
Report Date |
04/09/2021 |
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 Model Number | 21-7343-24 |
Device Catalogue Number | 21-7343-24 |
Device Lot Number | 3984193 |
Was Device Available for Evaluation? |
No
|
Date Returned to Manufacturer | 12/10/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/02/2020 |
Initial Date FDA Received | 12/29/2020 |
Supplement Dates Manufacturer Received | 03/14/2021
|
Supplement Dates FDA Received | 04/09/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|