Brand Name | PAXGENE® BLOOD RNA TUBE |
Type of Device | RNA PREANALYTICAL SYSTEMS |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
|
Manufacturer (Section G) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7602570 |
MDR Text Key | 111641887 |
Report Number | 9617032-2018-01622 |
Device Sequence Number | 1 |
Product Code |
NTW
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | DEN050003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/31/2018 |
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 |
Other
|
Device Expiration Date | 04/30/2017 |
Device Catalogue Number | 762165 |
Device Lot Number | 5267180 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/15/2016
|
Initial Date FDA Received | 06/14/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/24/2015 |
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 |
Patient Outcome(s) |
Other;
|