Brand Name | BD FLU+¿ SYRINGE |
Type of Device | PISTON SYRINGE |
Manufacturer (Section D) |
BECTON DICKINSON, S.A. |
cr mequinenza |
s/n |
fraga, huesca 22520 |
SP 22520 |
|
Manufacturer (Section G) |
BECTON DICKINSON, S.A. |
cr mequinenza |
s/n |
fraga, huesca 22520 |
SP
22520
|
|
Manufacturer Contact |
phillip
emmert
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 14022664 |
MDR Text Key | 288682549 |
Report Number | 3002682307-2022-00106 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K203359 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/21/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/06/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 305832 |
Device Lot Number | 2006429 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/17/2020 |
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 |
|
|