Brand Name | CADD MS3 PUMP |
Type of Device | PUMP, INFUSION |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan ln n |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 18995848 |
MDR Text Key | 338931879 |
Report Number | 3012307300-2024-01860 |
Device Sequence Number | 1 |
Product Code |
FRN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 7400 |
Device Catalogue Number | 21-7411-01 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2024 |
Date Manufacturer Received | 02/29/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/31/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|