FDA Adverse Event
Injury
Summary report: N
SAFETY FLEX CUFFED
MDR report key: 1222520
·
Received November 6, 2008
Report
- Report Number
- 2936999-2008-00556
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 9, 2008
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEATLHCARE
- Product Code
- BTR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE ENDOTRACHEAL 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 INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED "IN USE, AIR LEAKAGE OCCURRED, SO CHANGED TO OTHER TUBE." "WHEN A NURSE CHECKED THE USED TUBE, AIR LEAKAGE DID NOT OCCUR; NO PATIENT INJURED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFETY FLEX CUFFED | ENDOTRACHEAL TUBE | BTR | COVIDIEN, FORMERLY TYCO HEATLHCARE | 2007113520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |