Brand Name | CADD MEDICATION CASSETTE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
ST PAUL |
1265 grey fox rd. |
st. paul MN 55112 |
|
Manufacturer (Section G) |
ST PAUL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
7-1-1 akasaka, |
minneapolis, MN 55442
|
|
MDR Report Key | 14435252 |
MDR Text Key | 292017583 |
Report Number | 3012307300-2022-09091 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586027239 |
UDI-Public | 10610586027239 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K040636 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/18/2022 |
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 Model Number | 21-7302-24 |
Device Catalogue Number | 21-7302-24 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/11/2022 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/25/2022
|
Initial Date FDA Received | 05/19/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 64 YR |
Patient Sex | Female |
Patient Ethnicity | Non Hispanic |
|
|