Brand Name | BD VACUTAINER® PUSH BUTTON SET WITH 12 IN. TUBING AND HOLDER |
Type of Device | BLOOD COLLECTION SET |
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 | 7072692 |
MDR Text Key | 93819044 |
Report Number | 1024879-2017-00855 |
Device Sequence Number | 1 |
Product Code |
JKA
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K011984 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/02/2017 |
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 | 07/31/2017 |
Device Catalogue Number | 368657 |
Device Lot Number | 5205711 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/08/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/07/2016 |
Initial Date FDA Received | 11/30/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/24/2015 |
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;
|
|
|