Brand Name | DELTEC |
Type of Device | PORT-CATHETER,IMPLANTED,SUBCUTANEOUS,INTRAVASCULAR |
Manufacturer (Section D) |
ST PAUL |
1265 grey fox rd. |
st. paul MN 55112 |
|
Manufacturer (Section G) |
NULL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 11615300 |
MDR Text Key | 243812229 |
Report Number | 3012307300-2021-02840 |
Device Sequence Number | 1 |
Product Code |
LJT
|
UDI-Device Identifier | 10610586032776 |
UDI-Public | 10610586032776 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | KO726570 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/31/2023 |
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 |
Health Professional
|
Device Model Number | 21-4483-24 |
Device Catalogue Number | 21-4483-24 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/29/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/08/2021 |
Initial Date FDA Received | 04/05/2021 |
Supplement Dates Manufacturer Received | 12/17/2021
|
Supplement Dates FDA Received | 05/31/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 34 YR |
Patient Sex | Female |
Patient Weight | 58 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |