Brand Name | CADD CLEO INFUSION 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 |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15591540 |
MDR Text Key | 307033381 |
Report Number | 3012307300-2022-23598 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 30610586028407 |
UDI-Public | 30610586028407 |
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K042172 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Non-Healthcare Professional
|
Report Date |
10/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/12/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 21-7231-24 |
Device Catalogue Number | 21-7231-24 |
Device Lot Number | 6FN169B |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/16/2018 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/30/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |