Brand Name | BD VACUTAINER® K2 EDTA (K2E) 7.2MG 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 |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 14058875 |
MDR Text Key | 288988755 |
Report Number | 1917413-2022-00180 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 00382903678617 |
UDI-Public | 00382903678617 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | BK050036 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/03/2022 |
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 | 05/31/2023 |
Device Catalogue Number | 367861 |
Device Lot Number | 2018855 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/28/2022 |
Initial Date FDA Received | 04/08/2022 |
Supplement Dates Manufacturer Received | 06/03/2022
|
Supplement Dates FDA Received | 06/07/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/18/2022 |
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 |