FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM 6.0 TTS TRACHEOSTOMY TUBE
MDR report key: 2232921
·
Received July 21, 2011
Report
- Report Number
- 2183502-2011-00545
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 19, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- JOH
- PMA / PMN Number
- K923878A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAD NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. 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 EVALUATION.
Description of Event or Problem · 1
ACCORDING TO REPORTER, A CARDINAL 10FR SUCTION CATHETER COULD NOT BE EASILY PASSED THROUGH THE PRODUCT DURING USE. THE TRACH WAS REPLACED WITH A DIFFERENT DEVICE. NO LONG TERM INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA CUSTOM 6.0 TTS TRACHEOSTOMY TUBE | JOH - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC | NA | CL88926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |