Brand Name | DELTEC PORT-A-CATH LOW PROFILE IMPLANTABLE VENOU |
Type of Device | PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, |
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 |
minneapolis, MN 55442
|
|
MDR Report Key | 15334475 |
MDR Text Key | 305538168 |
Report Number | 3012307300-2022-17198 |
Device Sequence Number | 1 |
Product Code |
LJT
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K942024 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/01/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/01/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Expiration Date | 10/18/2021 |
Device Catalogue Number | 21-4071-24 |
Device Lot Number | 3341517 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/22/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/19/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/20/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|