Brand Name | BD ULTRA-FINE¿ INSULIN SYRINGE |
Type of Device | INSULIN SYRINGE WITH NEEDLE |
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 |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 7575511 |
MDR Text Key | 110473573 |
Report Number | 1920898-2018-00408 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K941657 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 326666 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/16/2018 |
Initial Date FDA Received | 06/06/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
|