FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS TRACHEOSTOMY TUBE
MDR report key: 2160508
·
Received July 1, 2011
Report
- Report Number
- 2183502-2011-00515
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 30, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K913859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT PRODUCT'S INFLATION LINE LEAKED DURING USE AFTER 125 HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA TTS TRACHEOSTOMY TUBE | JOH-TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 1835007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |