Brand Name | BD MICRO-FINE PLUS 32GA X 4MM PEN NEEDLE |
Type of Device | PEN NEEDLE, 32G X 4MM |
Manufacturer (Section D) |
BD |
1 becton dr. |
franklin lakes NJ 07417 |
|
Manufacturer (Section G) |
POTTERY RD |
dun laoghaire, co. |
|
dublin |
EI
|
|
Manufacturer Contact |
amy
bodell
|
1 becton dr. |
franklin lakes, NJ 07417
|
8015652585
|
|
MDR Report Key | 4017751 |
MDR Text Key | 4712198 |
Report Number | 2243072-2014-00159 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
07/30/2014 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 320136 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/15/2014
|
Initial Date FDA Received | 07/30/2014 |
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) |
Required Intervention;
|
|
|