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 |
|
MDR Report Key | 7532194 |
MDR Text Key | 108986823 |
Report Number | 9617032-2018-01272 |
Device Sequence Number | 1 |
Product Code |
NTW
|
Combination Product (y/n) | N |
PMA/PMN Number | DEN050003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Type of Report
| Initial,Followup |
Report Date |
06/07/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/22/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 02/29/2016 |
Device Catalogue Number | 762165 |
Device Lot Number | 4244464 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/16/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|