FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE
MDR report key: 3983906
·
Received June 24, 2014
Report
- Report Number
- 2183502-2014-00439
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Report Date
- June 23, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K923878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
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 ALLEGING THAT THE TRACHEOSTOMY TUBE CUFF WAS FOUND TO BE LEAKING AT THE CUFF AFTER 12 HOURS IN USE. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368074 | BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE | JOH - TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL MD, INC. | NA | CS011997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |