Brand Name | MEDEX¿ MANIFOLD |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
SMITHS MEDICAL, ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
DUBLIN SHARED SERVICES CENTER |
5200 upper metro place |
suite 200 |
dublin OH 43017 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7598387 |
MDR Text Key | 110970093 |
Report Number | 3012307300-2018-02321 |
Device Sequence Number | 1 |
Product Code |
FMG
|
UDI-Device Identifier | 10351688504142 |
UDI-Public | 10351688504142 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/27/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | MX934Z4LM |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/16/2018 |
Initial Date FDA Received | 06/13/2018 |
Supplement Dates Manufacturer Received | 07/18/2018
|
Supplement Dates FDA Received | 07/27/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
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) |
Life Threatening;
|
Patient Age | 79 YR |
|
|