Brand Name | PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES |
Type of Device | TUBE TRACHEOSTOMY AND TUBE CUFF |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd avenue |
|
gary IN 46406 |
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6487537 |
MDR Text Key | 72652191 |
Report Number | 3012307300-2017-00836 |
Device Sequence Number | 1 |
Product Code |
JOH
|
UDI-Device Identifier | 15021312006308 |
UDI-Public | 15021312006308 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K083641 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/12/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Patient Family Member or Friend
|
Device Expiration Date | 02/28/2021 |
Device Catalogue Number | 67P055 |
Device Lot Number | 3135344 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/21/2017
|
Initial Date FDA Received | 04/12/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/18/2016 |
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 |
Patient Outcome(s) |
Required Intervention;
|