Brand Name | PORTEX |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
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 |
2, 2-jou kudaru, kawaharamachi |
minneapolis, MN 55442
|
|
MDR Report Key | 15329742 |
MDR Text Key | 305350664 |
Report Number | 3012307300-2022-17098 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 10351688434067 |
UDI-Public | 10351688434067 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/31/2022 |
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 Model Number | C37201370J |
Device Catalogue Number | C37101307J |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/17/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/07/2022 |
Initial Date FDA Received | 08/31/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|