Brand Name | BD KIESTRA INOQULA |
Type of Device | DEVICE, MICROTITER DILUTING/DISPENSING |
Manufacturer (Section D) |
BD KIESTRA LAB AUTOMATION |
6 marconilaan |
drachten KY |
|
Manufacturer (Section G) |
BD KIESTRA LAB AUTOMATION |
6 marconilaan |
|
drachten KY |
|
Manufacturer Contact |
jo
doyka
|
7 loveton circle |
sparks, MD 21152
|
4103164000
|
|
MDR Report Key | 18722776 |
MDR Text Key | 336622728 |
Report Number | 3010141591-2024-00002 |
Device Sequence Number | 1 |
Product Code |
JTC
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/12/2024 |
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 Catalogue Number | 447202 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/26/2024
|
Initial Date FDA Received | 02/16/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/26/2021 |
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 |