Brand Name | BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE |
Type of Device | TUBE TRACHEOSTOMY AND TUBE CUFF |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
Manufacturer Contact |
reed
covert
|
6000 nathan lane north |
minneapolis, MN 55442
|
2247062300
|
|
MDR Report Key | 19185362 |
MDR Text Key | 341295495 |
Report Number | 3012307300-2024-03042 |
Device Sequence Number | 1 |
Product Code |
JOH
|
UDI-Device Identifier | 15021312006094 |
UDI-Public | (01)15021312006094(17)270711(10)4308123 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K083641 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
04/25/2024 |
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 |
Health Professional
|
Device Catalogue Number | 670190 |
Device Lot Number | 4308123 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/23/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/28/2024
|
Initial Date FDA Received | 04/25/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/11/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
Patient Sex | Male |