Brand Name | PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS |
Type of Device | CONNECTOR, AIRWAY (EXTENSION) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis, MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA |
10 bowman drive |
|
keene NH 03431 0724 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, MN 55442
|
7633833310
|
|
MDR Report Key | 7844336 |
MDR Text Key | 119498872 |
Report Number | 3012307300-2018-03579 |
Device Sequence Number | 1 |
Product Code |
BZA
|
UDI-Device Identifier | 10788942619913 |
UDI-Public | 10788942619913 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/04/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 01/17/2023 |
Device Catalogue Number | 66-1991 |
Device Lot Number | 3572937 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/08/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/18/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |