Brand Name | LANGSTON DUAL LUMEN CATHETER |
Type of Device | CATHETER |
Manufacturer (Section D) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
maple grove MN 55369 |
|
Manufacturer (Section G) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
|
maple grove MN 55369 |
|
Manufacturer Contact |
renee
runtsch
|
6464 sycamore court north |
maple grove, MN 55369
|
7636564366
|
|
MDR Report Key | 3944090 |
MDR Text Key | 4536365 |
Report Number | 2134812-2014-00023 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061565 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Physician Assistant
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
04/08/2014 |
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 |
Physician
|
Device Expiration Date | 01/31/2016 |
Device Model Number | 5540 |
Device Lot Number | 569964 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/15/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/08/2014 |
Initial Date FDA Received | 07/18/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/30/2014 |
Is the Device Single Use? |
Yes
|
Removal/Correction Number | 2134812-05/23/2014-01R |
Patient Sequence Number | 1 |