Brand Name | CENTROSFLO LONG-TERM DIALYSIS CATHETER |
Type of Device | LONG-TERM DIALYSIS CATHETER |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC |
1600 west merit parkway |
south jordan UT 84095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC |
1600 west merit parkway |
|
south jordan UT 84095 |
|
Manufacturer Contact |
casey
hughes, ms, cqe
|
1600 west merit parkway |
south jordan, UT 84095
|
8013164932
|
|
MDR Report Key | 5954404 |
MDR Text Key | 54886655 |
Report Number | 1721504-2016-00175 |
Device Sequence Number | 1 |
Product Code |
MSD
|
Combination Product (y/n) | N |
Reporter Country Code | TH |
PMA/PMN Number | K141363 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/22/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/15/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/30/2015 |
Device Catalogue Number | CENF19K |
Device Lot Number | H563061 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/17/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/13/2014 |
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 |
|
|