FDA Adverse Event
Injury
Summary report: N
SHILEY DISPOSABLE CANNULA LPC
MDR report key: 1101807
·
Received August 6, 2008
Report
- Report Number
- 2936999-2008-00353
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 9, 2008
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE DISPOSABLE CANNULA TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER IS UNK. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. 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
IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS IN THE PT FOR 4 DAYS AND THE CUFF DEFLATED DUE TO A LEAK. THE TUBE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY DISPOSABLE CANNULA LPC | TRACHEOSTOMY TUBE | BTO | COVIDIEN/FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |