FDA Adverse Event
Malfunction
Summary report: N
BIVONA TTS TRACHEOSTOMY TUBE
MDR report key: 3173225
·
Received June 6, 2013
Report
- Report Number
- 2183502-2013-00303
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- April 1, 2013
- Report Date
- May 7, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K913859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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 THAT ALLEGES THAT THE TRACHEOSTOMY TUBE SUSTAINED DAMAGE AT THE CUFF. REPLACEMENT WAS REQUIRED DUE TO LEAKING 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 |
|---|---|---|---|---|---|---|---|
| 251892 | BIVONA TTS TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL ASD, INC. | NA | 1704731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |