Brand Name | PORTEX BLUE LINE ULTRA SUCTIONAID |
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) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
boundary road |
|
hythe, kent CT21 6JL |
UK
CT21 6JL
|
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
sapporo city, hokkaido |
minneapolis, MN 55442
|
|
MDR Report Key | 12808284 |
MDR Text Key | 280768539 |
Report Number | 3012307300-2021-11197 |
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
|
Type of Report
| Initial,Followup |
Report Date |
03/08/2022 |
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 |
Device Lot Number | 4072307 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/28/2021 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/22/2021 |
Initial Date FDA Received | 11/13/2021 |
Supplement Dates Manufacturer Received | 02/08/2022
|
Supplement Dates FDA Received | 03/08/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|