FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE
MDR report key: 3173226
·
Received June 6, 2013
Report
- Report Number
- 2183502-2013-00299
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 6, 2013
- Report Date
- June 5, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K944178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251981 | BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | CL117018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |