Brand Name | NRFIT CADD MEDICATION CASSETTE |
Type of Device | SET, I.V. FLUID TRANSFER |
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 |
7-1-1 akasaka |
minneapolis, MN 55442
|
|
MDR Report Key | 15784250 |
MDR Text Key | 307567410 |
Report Number | 3012307300-2022-27061 |
Device Sequence Number | 1 |
Product Code |
LHI
|
UDI-Device Identifier | 10610586044014 |
UDI-Public | 10610586044014 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K162219 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/11/2022 |
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 | 21-7609-24 |
Device Catalogue Number | 21-7609-24 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/31/2022 |
Initial Date FDA Received | 11/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|