Brand Name | PORTEX® ENDOTRACHEAL TUBE |
Type of Device | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, mn |
|
Manufacturer (Section G) |
NULL |
6000 nathan lane n |
|
minneapolis, mn |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, mn
|
3833310
|
|
MDR Report Key | 10029168 |
MDR Text Key | 190014868 |
Report Number | 3012307300-2020-03785 |
Device Sequence Number | 1 |
Product Code |
CBI
|
UDI-Device Identifier | 15019315058615 |
UDI-Public | 15019315058615 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K953483 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/17/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/06/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Expiration Date | 06/19/2022 |
Device Model Number | 198-35L |
Device Catalogue Number | 198-35L |
Device Lot Number | 3824846 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/17/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/15/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/17/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |