Brand Name | MEDEX STOPCOCK |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6250 shier rings road |
dublin OH 43016 |
|
Manufacturer (Section G) |
NULL |
6250 shier rings road |
|
dublin OH 43016 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 16487765 |
MDR Text Key | 310725549 |
Report Number | 3012307300-2023-02048 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 10351688507648 |
UDI-Public | 10351688507648 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/14/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MX4341L |
Device Catalogue Number | MX4341L |
Device Lot Number | 4324271 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/09/2023
|
Initial Date FDA Received | 03/06/2023 |
Supplement Dates Manufacturer Received | 04/18/2024
|
Supplement Dates FDA Received | 05/15/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/08/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|