Brand Name | NEXSITE STEPPED TIP |
Type of Device | HEMODIALYSIS CATHETER |
Manufacturer (Section D) |
MARVAO MEDICAL |
innovation in business centre, |
gmit, dublin road, |
galway, |
EI |
|
Manufacturer Contact |
fiona
geraghty
|
innovation in business centre |
gmit, dublin road, |
galway,
|
EI
|
91759301
|
|
MDR Report Key | 5681246 |
MDR Text Key | 45956664 |
Report Number | 3008110587-2016-00021 |
Device Sequence Number | 1 |
Product Code |
MSD
|
UDI-Device Identifier | 05391525640020 |
UDI-Public | (01)05391525640020(17)160101(10)39413 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121933 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
study |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/03/2016 |
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? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 01/01/2016 |
Device Catalogue Number | NEXHD1552801 |
Device Lot Number | 39413 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/03/2016
|
Initial Date FDA Received | 05/26/2016 |
Date Device Manufactured | 01/13/2015 |
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 |
Treatment | CATHFLO ACTIVASE |
Patient Outcome(s) |
Death;
|
Patient Age | 61 YR |
Patient Weight | 54 |
|
|