Brand Name | PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD; INC. |
6000 nathan lane n |
minneapolis,, mn |
|
Manufacturer (Section G) |
SMITHS MEDICAL INTERNATIONAL LTD. |
boundary road |
|
hythe, kent CT21 6JL |
UK
CT21 6JL
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis,, mn
|
3833310
|
|
MDR Report Key | 9832658 |
MDR Text Key | 183474258 |
Report Number | 3012307300-2020-02021 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 10351688419446 |
UDI-Public | 10351688419446 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K002506 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/13/2020 |
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 |
No Information
|
Device Expiration Date | 10/23/2022 |
Device Model Number | 650904 |
Device Catalogue Number | 650904 |
Device Lot Number | 3898376 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/13/2020
|
Initial Date FDA Received | 03/14/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/25/2019 |
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 |
|
|