Brand Name | SYRINGE 0.3ML 29GA 1/2IN |
Type of Device | PISTON SYRINGE |
Manufacturer (Section D) |
BD MEDICAL - DIABETES CARE |
1329 west highway 6 |
holdrege NE 68949 |
|
Manufacturer (Section G) |
BD MEDICAL - DIABETES CARE |
1329 west highway 6 |
|
holdrege NE 68949 |
|
Manufacturer Contact |
katie
swenson
|
9450 south state street |
sandy, UT 84070
|
8015296192
|
|
MDR Report Key | 12415451 |
MDR Text Key | 269626300 |
Report Number | 1920898-2021-00953 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K024112 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,health profe |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/20/2021 |
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 |
Lay User/Patient
|
Device Catalogue Number | 326631 |
Device Lot Number | 0160988 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/04/2021 |
Initial Date FDA Received | 09/02/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/08/2020 |
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 |