Brand Name | BD MICROTAINER® BLOOD COLLECTION TUBES |
Type of Device | BLOOD COLLECTION TUBE |
Manufacturer (Section D) |
BD CARIBE LTD. |
road 31 |
k.m. 24.3 |
juncos |
|
Manufacturer (Section G) |
BD CARIBE LTD. |
road 31 |
k.m. 24.3 |
juncos |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7077977 |
MDR Text Key | 94737425 |
Report Number | 2618282-2017-00031 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K991702 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/24/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 06/30/2018 |
Device Catalogue Number | 365968 |
Device Lot Number | 7095632 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/30/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/22/2017 |
Initial Date FDA Received | 12/03/2017 |
Supplement Dates Manufacturer Received | 06/22/2017
|
Supplement Dates FDA Received | 01/24/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/05/2017 |
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 |
Patient Outcome(s) |
Other;
|
|
|