Brand Name | BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR |
Type of Device | URINE 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 | 7098136 |
MDR Text Key | 94821040 |
Report Number | 1024879-2017-01036 |
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,Followup,Followup |
Report Date |
01/24/2018 |
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 Health Care Professional
|
Device Expiration Date | 01/31/2018 |
Device Catalogue Number | 366408 |
Device Lot Number | 6328897 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/11/2017 |
Initial Date FDA Received | 12/07/2017 |
Supplement Dates Manufacturer Received | 05/11/2017 05/11/2017
|
Supplement Dates FDA Received | 01/23/2018 01/24/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/23/2016 |
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;
|
|
|