Brand Name | PORTEX BLUSELECT DILATION TRACHESTOMY KIT |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
boundary road |
hythe, kent CT21 6JL |
UK CT21 6JL |
|
Manufacturer (Section G) |
NULL |
boundary road |
|
hythe, kent CT21 6JL |
UK
CT21 6JL
|
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
7-15-26 fukushima, |
minneapolis, MN 55442
|
|
MDR Report Key | 15043453 |
MDR Text Key | 304129629 |
Report Number | 3012307300-2022-13529 |
Device Sequence Number | 1 |
Product Code |
BTO
|
UDI-Device Identifier | 15019517076158 |
UDI-Public | 15019517076158 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K173384 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/26/2023 |
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 |
Health Professional
|
Device Model Number | 101/860/080CZ |
Device Catalogue Number | 101/860/080CZ |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/27/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/22/2022
|
Initial Date FDA Received | 07/18/2022 |
Supplement Dates Manufacturer Received | 05/24/2023
|
Supplement Dates FDA Received | 06/26/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |