Brand Name | PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE |
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 MEDICAL INTERNATIONAL LTD |
1 st. crispin way |
haslingden |
rossendale, lancashire BB4 4 PW |
UK
BB4 4PW
|
|
Manufacturer Contact |
jennifer
meng
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833078
|
|
MDR Report Key | 6745052 |
MDR Text Key | 81086821 |
Report Number | 3012307300-2017-01602 |
Device Sequence Number | 1 |
Product Code |
BTO
|
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,health professional,o |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
07/26/2017 |
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? |
Yes
|
Device Operator |
Nurse
|
Device Expiration Date | 03/19/2017 |
Device Catalogue Number | 100/850/060 |
Device Lot Number | 2175351 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/05/2017 |
Initial Date FDA Received | 07/26/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/20/2012 |
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 |