Brand Name | BD SYRINGE WITH ULTRA-FINE¿ NEEDLE |
Type of Device | SYRINGE WITH NEEDLE |
Manufacturer (Section D) |
BECTON DICKINSON DE MEXICO |
autopista |
55 59 99 8400, k.m. 37.5 |
cuautitlan izcalli |
|
Manufacturer (Section G) |
BECTON DICKINSON DE MEXICO |
autopista |
55 59 99 8400, k.m. 37.5 |
cuautitlan izcalli |
|
Manufacturer Contact |
brett
wilko
|
9450 south state street |
sandy, UT 84070
|
8015652845
|
|
MDR Report Key | 8043375 |
MDR Text Key | 128257527 |
Report Number | 9614033-2018-00083 |
Device Sequence Number | 1 |
Product Code |
FMF
|
UDI-Device Identifier | 00382903267866 |
UDI-Public | 382903267866 |
Combination Product (y/n) | N |
Reporter Country Code | MX |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/01/2018 |
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 |
Lay User/Patient
|
Device Expiration Date | 01/31/2023 |
Device Catalogue Number | 326786 |
Device Lot Number | 7352815 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/16/2018 |
Initial Date FDA Received | 11/06/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/30/2018 |
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;
|
|
|