Brand Name | 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE |
Type of Device | BLOOD COLLECTION TUBE |
Manufacturer (Section D) |
BECTON, DICKINSON & CO. |
150 south 1st avenue |
broken bow NE 68822 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO. |
150 south 1st avenue |
|
broken bow NE 68822 |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7059047 |
MDR Text Key | 93479325 |
Report Number | 1917413-2017-00219 |
Device Sequence Number | 1 |
Product Code |
JKA
|
UDI-Device Identifier | 50382903630832 |
UDI-Public | 50382903630832 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K013971 |
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 |
10/30/2017 |
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 Catalogue Number | 363083 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/21/2016 |
Initial Date FDA Received | 11/27/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|