FDA Adverse Event
Malfunction
Summary report: N
BIVONA
MDR report key: 13583303
·
Received February 23, 2022
Report
- Report Number
- 3012307300-2022-03898
- Event Type
- Malfunction
- Date Received
- February 23, 2022
- Report Date
- February 23, 2022
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- UDI-DI
- 10351688518682
- PMA / PMN Number
- K923878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION (02/09/2022): NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Additional Manufacturer Narrative · 0
DEVICE EVALUATION (02/09/2022): NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THE DEVICE WAS LEAKING. THE DEVICE WILL NOT BE RETURNED (THE CAREGIVER DISCARDED THE COMPLAINT PRODUCT). NO PATIENT INJURY WAS REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THE DEVICE WAS LEAKING. THE DEVICE WILL NOT BE RETURNED (THE CAREGIVER DISCARDED THE COMPLAINT PRODUCT). NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 930357 | BIVONA | TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS MEDICAL ASD, INC. | 67PFSS35 | 4176238 | 10351688518682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |