FDA Adverse Event
Injury
Summary report: N
BRONCHO CATH RIGHT
MDR report key: 1190375
·
Received October 3, 2008
Report
- Report Number
- 2936999-2008-00493
- Event Type
- Injury
- Date Received
- October 3, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- CBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE ENDOBRONCHIAL TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURER WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUFF OF THE ENDOBRONCHIAL TUBE LEAKED AFTER PATIENT INTUBATION, AND THE PATIENT WAS RE-INTUBATED. IT WAS REPORTED THAT THE CUFF WAS PRE-TESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRONCHO CATH RIGHT | ENDOBRONCHIAL TUBE | CBI | COVIDIEN/FORMERLY TYCO HEALTHCARE | 2008056810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |