FDA Adverse Event
Malfunction
Summary report: N
BIVONA CUSTOM TTS TRACHEOSTOMY TUBE
MDR report key: 3963962
·
Received May 22, 2014
Report
- Report Number
- 2183502-2014-00324
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- May 20, 2014
- Manufacturer
- SMITHS MEDICAL, INC.
- Product Code
- JOH
- PMA / PMN Number
- K923878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
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. MANUFACTURER'S REFERENCE# (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT ONE OF THE EYELETS ON THE TRACHEOSTOMY TUBE FLANGE BROKE DURING USE. THE TUBE HAD BEEN IN SITU FOR AN UNKNOWN AMOUNT OF TIME PRIOR TO THE BREAKAGE. REPLACEMENT OF THE TUBE WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304381 | BIVONA CUSTOM TTS TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |