Brand Name | PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT |
Type of Device | BTO - TRACHEOSTOMY TUBE KIT |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL LTD. |
hythe, kent |
|
Manufacturer (Section G) |
SMITHS MEDICAL INTERNATIONAL LTD. |
boundry rd. |
|
hythe, kent CT21 6JL |
UK
CT21 6JL
|
|
Manufacturer Contact |
pete
hirte
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287384
|
|
MDR Report Key | 4032085 |
MDR Text Key | 4724885 |
Report Number | 2183502-2014-00557 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/04/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/05/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/28/2018 |
Device Catalogue Number | 100/870/080 |
Device Lot Number | 2491832 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/04/2014 |
Distributor Facility Aware Date | 07/14/2014 |
Device Age | 1 YR |
Event Location |
Hospital
|
Date Manufacturer Received | 07/17/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2013 |
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 |
|
|