Brand Name | PORTEX® PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
a d no.4 |
parque industrial internaciona |
tijuana, bc |
MX
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7138773 |
MDR Text Key | 95511864 |
Report Number | 3012307300-2017-02610 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
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 |
12/21/2017 |
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 |
No Information
|
Device Expiration Date | 02/18/2021 |
Device Catalogue Number | 100/810/060 |
Device Lot Number | 3159839 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/04/2017
|
Initial Date FDA Received | 12/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2016 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|