Brand Name | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
olomoucka 306 |
hranice 1, mesto 753 0 1 |
EZ 753 01 |
|
Manufacturer (Section G) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
olomoucka 306 |
|
hranice 1, mesto 753 0 1 |
EZ
753 01
|
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
tambore ? santana de |
minneapolis, MN 55442
|
|
MDR Report Key | 16430982 |
MDR Text Key | 310161176 |
Report Number | 3012307300-2023-01578 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K030381 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/23/2023 |
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 | 100/810/080 |
Device Catalogue Number | 100/810/080CZ |
Device Lot Number | 4034791 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/01/2023 |
Initial Date FDA Received | 02/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/18/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|