Brand Name | SET ADMINISTRATION INTRAVASCULAR |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD,INC |
6000 lane n |
minneapolis, mn |
|
Manufacturer (Section G) |
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
ave calidad no. 4, |
parque industrial internaciona |
tijuana, b.c. 22425 |
MX
22425
|
|
Manufacturer Contact |
dave
halverson
|
6000 lane n |
minneapolis, mn
|
3833310
|
|
MDR Report Key | 10235453 |
MDR Text Key | 197671366 |
Report Number | 3012307300-2020-06685 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586029745 |
UDI-Public | 10610586029745 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K072059 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/06/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/06/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | NDL, GRIPPER MICRO, 22G X .75 12/BOX |
Device Catalogue Number | 21-3251-24 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/09/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/04/2019 |
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 |