FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM 3.5 FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 3063079
·
Received February 19, 2013
Report
- Report Number
- 2183502-2013-00031
- Event Type
- Malfunction
- Date Received
- February 19, 2013
- Report Date
- February 14, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K944178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS 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 SUCTION CATHETER COULD NOT BE PASSED THROUGH THE PRODUCT DURING USE. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72792 | BIVONA CUSTOM 3.5 FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |