Brand Name | CADD LEGACY 1 PUMP |
Type of Device | PUMP, INFUSION |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis, mn |
|
MDR Report Key | 9772575 |
MDR Text Key | 181536317 |
Report Number | 3012307300-2020-01755 |
Device Sequence Number | 1 |
Product Code |
FRN
|
UDI-Device Identifier | 10610586019548 |
UDI-Public | 10610586019548 |
Combination Product (y/n) | N |
PMA/PMN Number | K982838 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor |
Type of Report
| Initial,Followup |
Report Date |
04/07/2020 |
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 |
Other
|
Device Model Number | 6400 |
Device Catalogue Number | 21-6400-51 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2020 |
Initial Date Manufacturer Received |
02/05/2020 |
Initial Date FDA Received | 02/29/2020 |
Supplement Dates Manufacturer Received | 03/05/2020
|
Supplement Dates FDA Received | 04/08/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|