Brand Name | DELTEC |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
ST PAUL |
1265 grey fox rd. |
st. paul MN 55112 |
|
MDR Report Key | 11672454 |
MDR Text Key | 245754601 |
Report Number | 3012307300-2021-03176 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586025570 |
UDI-Public | 10610586025570 |
Combination Product (y/n) | N |
PMA/PMN Number | K021999 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Type of Report
| Initial,Followup |
Report Date |
06/02/2021 |
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 | 21-2764-24 |
Device Catalogue Number | 21-2764-24 |
Device Lot Number | 3998755 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/06/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/19/2021 |
Initial Date FDA Received | 04/15/2021 |
Supplement Dates Manufacturer Received | 05/31/2021
|
Supplement Dates FDA Received | 06/02/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|