Brand Name | MEDEX¿ SMALL BORE STOPCOCKS |
Type of Device | STOPCOCK, I.V. SET |
Manufacturer (Section D) |
SMITHS MEDICAL ASD INC., |
1265 grey fox rd |
st. paul MN 55112 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD INC., |
1265 grey fox rd |
|
st. paul MN 55112 |
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox rd |
st. paul, MN 55112
|
7633833052
|
|
MDR Report Key | 5749300 |
MDR Text Key | 48188210 |
Report Number | 2183502-2016-01251 |
Device Sequence Number | 1 |
Product Code |
FMG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,health profe |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/26/2016 |
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 | MX5311L |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/16/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/26/2016
|
Initial Date FDA Received | 06/24/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/23/2016
|
Was Device Evaluated by Manufacturer? |
No
|
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;
Required Intervention;
|
|
|