FDA Adverse Event
Injury
Summary report: N
SHILEY LPC
MDR report key: 1060625
·
Received June 13, 2008
Report
- Report Number
- 2936999-2008-00262
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 19, 2008
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE TRACHEOSTOMY TUBE AND THE 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 INNER CANNULA IS NOT STAYING LOCKED TO THE OUTER CANNULA. THE PT IS ON A VENT AT TV=700, FIO2=30, PEEP=2 1/2. THE INNER CANNULA IS CLEANED WITH PEROXIDE/SALINE AND SALINE WASH EVERY 8 HRS. THE TRACHEOSTOMY TUBE IS IN THE PT AND WILL BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LPC | TRACHEOSTOMY TUBE | BTO | COVIDIEN, FORMERLY TYCO HEALTHCARE | LPC | 0802002065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |