Brand Name | SMITHS MEDICAL CADD CLEO INFUSION SETS |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane n |
minneapolis, mn |
|
MDR Report Key | 9762725 |
MDR Text Key | 181144239 |
Report Number | 3012307300-2020-01540 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586028335 |
UDI-Public | 10610586028335 |
Combination Product (y/n) | N |
PMA/PMN Number | K042172 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Type of Report
| Initial,Followup |
Report Date |
04/01/2020 |
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 |
No Information
|
Device Expiration Date | 07/19/2023 |
Device Catalogue Number | 21-7220-24 |
Device Lot Number | 3677257 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/22/2020 |
Initial Date FDA Received | 02/27/2020 |
Supplement Dates Manufacturer Received | 03/03/2020
|
Supplement Dates FDA Received | 04/01/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|