Brand Name | BD PHOENIX PANEL NMIC-306 |
Type of Device | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY |
Manufacturer (Section D) |
BECTON DICKINSON & CO. (SPARKS) |
7 loveton circle |
sparks MD 21152 |
|
Manufacturer (Section G) |
BECTON, DICKINSON & CO. (SPARKS) |
7 loveton circle |
|
sparks MD 21152 |
|
Manufacturer Contact |
jo
doyka
|
7 loveton circle |
sparks, MD 21152
|
4103164000
|
|
MDR Report Key | 18903842 |
MDR Text Key | 337666780 |
Report Number | 1119779-2024-00205 |
Device Sequence Number | 1 |
Product Code |
LON
|
UDI-Device Identifier | 00382904492922 |
UDI-Public | (01)00382904492922 |
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
03/01/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/14/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 449292 |
Device Lot Number | 3311874 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/21/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/07/2023 |
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 |