Brand Name | BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES |
Type of Device | BLOOD SPECIMEN COLLECTION DEVICE |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
UK |
|
Manufacturer (Section G) |
BECTON, DICKINSON AND COMPANY (BD) |
belliver way |
belliver industrial estate |
plymouth |
UK
|
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 11379899 |
MDR Text Key | 233748167 |
Report Number | 9617032-2021-00193 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 50382903668828 |
UDI-Public | 50382903668828 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | BK050036 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/04/2021 |
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 |
Health Professional
|
Device Expiration Date | 05/31/2021 |
Device Model Number | 366882 |
Device Catalogue Number | 366882 |
Device Lot Number | 0157868 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/01/2021 |
Initial Date FDA Received | 02/25/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/05/2020 |
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 |