FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS TRACHEOSTOMY TUBE
MDR report key: 1781367
·
Received July 30, 2010
Report
- Report Number
- 2183502-2010-00336
- Event Type
- Malfunction
- Date Received
- July 30, 2010
- Date of Event
- July 2, 2010
- Report Date
- July 28, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER GREATER THE 1 HOUR IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |