Brand Name | 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE |
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 | 7088366 |
MDR Text Key | 94522300 |
Report Number | 1024879-2017-00304 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 00382903679867 |
UDI-Public | 00382903679867 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K023075 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/25/2017 |
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 | 11/30/2016 |
Device Catalogue Number | 367986 |
Device Lot Number | 5316737 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/06/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/25/2016 |
Initial Date FDA Received | 12/06/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/12/2015 |
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;
|
|
|