Brand Name | CADD LEGACY PCA PUMP |
Type of Device | PUMP, INFUSION, PCA |
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 | 19112549 |
MDR Text Key | 340710464 |
Report Number | 3012307300-2024-02594 |
Device Sequence Number | 1 |
Product Code |
MEA
|
UDI-Device Identifier | 10610586019357 |
UDI-Public | 10610586019357 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K982839 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/15/2024 |
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 | 6300 |
Device Catalogue Number | 21-6300-02 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/19/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/19/2024 |
Initial Date FDA Received | 04/15/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/20/2017 |
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 |
|
|