Brand Name | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER |
Type of Device | VACUTAINER |
Manufacturer (Section D) |
BECTON, DICKINSON & CO., (BD) |
1575 airport road |
sumter SC 29153 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO., (BD) |
1575 airport road |
|
sumter SC 29153 |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7088364 |
MDR Text Key | 94817427 |
Report Number | 1024879-2017-00287 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 00382903686568 |
UDI-Public | 00382903686568 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K011984 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/24/2017 |
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 | 08/31/2017 |
Device Catalogue Number | 368656 |
Device Lot Number | 5226706 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/21/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/14/2016 |
Initial Date FDA Received | 12/06/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/14/2015 |
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;
|
|
|