Brand Name | PORTEX® BLUE LINE ULTRA® SUCTIONAID 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 MEDICAL CZECH REPUBLIC A. S. |
olomoucká 306 |
hranice 1 - mesto |
hranice, 75301 |
EZ
75301
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7514402 |
MDR Text Key | 108260687 |
Report Number | 3012307300-2018-01527 |
Device Sequence Number | 1 |
Product Code |
BTO
|
UDI-Device Identifier | 15019315104862 |
UDI-Public | 15019315104862 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K030570 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor,foreign |
Reporter Occupation |
Other
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
05/15/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 10/12/2022 |
Device Catalogue Number | 100/870/080CZ |
Device Lot Number | 3491604 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/02/2018 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/18/2018 |
Initial Date FDA Received | 05/15/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/31/2017 |
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 |