Brand Name | PEN NDL 32G 4MM PRO 100 BOX 1200 US |
Type of Device | NEEDLE, HYPODERMIC, SINGLE LUMEN |
Manufacturer (Section D) |
BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND |
|
|
Manufacturer (Section G) |
BECTON DICKNSON AND CO. |
1 becton drive |
|
franklin lakes, NJ 07417 |
|
Manufacturer Contact |
avital
merl
|
300 kimball dr. |
parsippany, NJ 07054
|
|
MDR Report Key | 18498777 |
MDR Text Key | 333205957 |
Report Number | 9616656-2024-05017 |
Device Sequence Number | 1 |
Product Code |
FMI
|
UDI-Device Identifier | 00382903205509 |
UDI-Public | (01)00382903205509 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K212015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/05/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/11/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 320550 |
Device Lot Number | 3087267 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/05/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/28/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|