Brand Name | SYRINGE 0.3ML 31GA 8MM TW |
Type of Device | 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 | 12357135 |
MDR Text Key | 267857608 |
Report Number | 1920898-2021-00922 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/23/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 328822 |
Device Lot Number | 9336008 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/16/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/27/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/02/2019 |
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 |