Brand Name | BD VACUTAINER NH (SODIUM HEPARIN) 170 I.U. 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 |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12242805 |
MDR Text Key | 264572392 |
Report Number | 9617032-2021-00835 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 50382903683807 |
UDI-Public | 50382903683807 |
Combination Product (y/n) | N |
Reporter Country Code | IS |
PMA/PMN Number | K041071 |
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 |
07/09/2021 |
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 | 10/31/2022 |
Device Model Number | 368380 |
Device Catalogue Number | 368480 |
Device Lot Number | 0307278 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/15/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/28/2021 |
Initial Date FDA Received | 07/28/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/02/2020 |
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 |