Brand Name | MEDEX TRANSTAR SINGLE MONITORING KIT |
Type of Device | PROBE, BLOOD-FLOW, EXTRAVASCULAR |
Manufacturer (Section D) |
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
carretera miguel alemán km21.7 |
apodaca nuevo leon |
MX |
|
Manufacturer Contact |
reed
covert
|
6000 nathan lane n |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 18914117 |
MDR Text Key | 337783293 |
Report Number | 9616567-2024-00043 |
Device Sequence Number | 1 |
Product Code |
DPT
|
UDI-Device Identifier | 10351688503992 |
UDI-Public | (01)10351688503992(17)251114(10)4346097 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K942377 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/15/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | MX9505T |
Device Lot Number | 4346097 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/20/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/29/2022 |
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 |