Brand Name | BD FACSCALIBUR¿ FLOW CYTOMETER |
Type of Device | COUNTER, DIFFERENTIAL CELL |
Manufacturer (Section D) |
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
2350 qume drive |
san jose CA 95131 |
|
Manufacturer (Section G) |
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
2350 qume drive |
|
san jose CA 95131 |
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 15554986 |
MDR Text Key | 306924502 |
Report Number | 2916837-2022-00287 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 00382903429752 |
UDI-Public | 00382903429752 |
Combination Product (y/n) | N |
Reporter Country Code | BC |
PMA/PMN Number | K923790 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/09/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 342975 |
Device Catalogue Number | 342975 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/27/2022 |
Initial Date FDA Received | 10/06/2022 |
Supplement Dates Manufacturer Received | 09/27/2022
|
Supplement Dates FDA Received | 11/15/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/22/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|