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 | 10803489 |
MDR Text Key | 215117024 |
Report Number | 3012307300-2020-11130 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586025655 |
UDI-Public | 10610586025655 |
Combination Product (y/n) | N |
PMA/PMN Number | K021999 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other |
Type of Report
| Initial,Followup |
Report Date |
11/30/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 21-2861-24 |
Device Catalogue Number | 21-2861-24 |
Device Lot Number | 3922529 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/08/2020 |
Initial Date FDA Received | 11/06/2020 |
Supplement Dates Manufacturer Received | 11/02/2020
|
Supplement Dates FDA Received | 11/30/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|