Brand Name | BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT |
Type of Device | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
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 | 7593910 |
MDR Text Key | 111206521 |
Report Number | 1917413-2018-01843 |
Device Sequence Number | 1 |
Product Code |
FMH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
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 |
05/22/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/12/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 09/30/2017 |
Device Catalogue Number | 364991 |
Device Lot Number | 6061887 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/22/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 07/13/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2016 |
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;
|