FDA Adverse Event
Injury
Summary report: N
SHILEY FEN LPC
MDR report key: 1060630
·
Received June 13, 2008
Report
- Report Number
- 2936999-2008-00291
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE TRACHEOSTOMY TUBE AND THE FENESTRATED INNER CANNULA FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE PT'S FENESTRATED INNER CANNULA CRACKED AT THE BOTTOM OF THE 15MM CONNECTOR DURING REMOVED FOR CLEANING. A NON-FENESTRATED INNER CANNULA WAS INSERTED AND THE FOLLOWING DAY THE TRACHEOSTOMY TUBE WAS CHANGED OUT SO THAT THEY WOULD HAVE A FENESTRATED INNER CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY FEN LPC | TRACHEOSTOMY TUBE | BTO | COVIDIEN/FORMERLY TYCO HEALTHCARE | FEN LPC | 0708001695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |