FDA Adverse Event
Malfunction
Summary report: N
BIVONA TUBES NEO/PED FLEXTEND PLUS
MDR report key: 22981574
·
Received September 5, 2025
Report
- Report Number
- 3012307300-2025-10339
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- July 1, 2025
- Report Date
- September 5, 2025
- Manufacturer
- SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- JOH
- PMA / PMN Number
- K923878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00242-00. THE DATE OF THAT SUBMISSION WAS 12-AUG-2025. B3: DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. D4: EXPIRATION DATE AND H4: MANUFACTURE DATE ARE UNKNOWN, NO LOT NUMBER HAS BEEN PROVIDED. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO USE IT, THE DEVICE WOULD NOT INFLATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322298 | BIVONA TUBES NEO/PED FLEXTEND PLUS | TUBE TRACHEOSTOMY AND TUBE CUFF | JOH | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. | 4449015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |