Brand Name | BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd ave |
gary IN 46406 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd ave |
|
gary IN 46406 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 15698425 |
MDR Text Key | 306897366 |
Report Number | 3012307300-2022-26495 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/31/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/31/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 09/07/2023 |
Device Catalogue Number | 60PFSS40 |
Device Lot Number | 3695825 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/25/2019 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/06/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/22/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |