Brand Name | BD TRAY SPN WHIT25G3.5 |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
CAREFUSION, INC |
400 east foster rd |
mannford OK 74044 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
400 east foster rd |
|
mannford OK 74044 |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12870138 |
MDR Text Key | 285699622 |
Report Number | 1625685-2021-00098 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | DISCRETION |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/16/2022 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 11/24/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 405671 |
Device Catalogue Number | 405671 |
Device Lot Number | 0001424055 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/16/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/09/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|