Brand Name | BD VACUTAINER K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES |
Type of Device | BLOOD SPECIMEN COLLECTION DEVICE |
Manufacturer (Section D) |
BECTON, DICKINSON & CO. (BROKEN BOW) |
150 south 1st avenue |
broken bow NE 68822 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO. (BROKEN BOW) |
150 south 1st avenue |
|
broken bow NE 68822 |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12081323 |
MDR Text Key | 265167023 |
Report Number | 1917413-2021-00549 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 50382903678414 |
UDI-Public | 50382903678414 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
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 |
06/09/2021 |
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 |
Other
|
Device Expiration Date | 02/28/2022 |
Device Model Number | 367841 |
Device Catalogue Number | 367841 |
Device Lot Number | 0316336 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/02/2021 |
Initial Date FDA Received | 06/28/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/11/2020 |
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 |