Brand Name | BLUE LINE ENDOBRONCHIAL TUBES |
Type of Device | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL |
boundary road |
hythe, kent CT216 JL |
UK CT216JL |
|
Manufacturer (Section G) |
SMITHS MEDICAL |
boundary road |
|
hythe, kent CT216 JL |
UK
CT216JL
|
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox road |
st. paul, MN 55112
|
7633833052
|
|
MDR Report Key | 5377628 |
MDR Text Key | 36342511 |
Report Number | 2183502-2016-00079 |
Device Sequence Number | 1 |
Product Code |
CBI
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
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 |
Report Date |
01/19/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/19/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/30/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|