FDA Adverse Event
Injury
Summary report: N
HI-LO
MDR report key: 2201971
·
Received August 4, 2011
Report
- Report Number
- 2936999-2011-00458
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 7, 2011
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K871204
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AIR LEAKED FROM THE CUFF DURING USE. THE TUBE WAS INSPECTED PRIOR TO USE. THE TUBE WAS REMOVED AND THE PT WAS RE-INTUBATE WITH A NEW (UNSPECIFIED) TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI-LO | ENDOTRACHEAL TUBE | BTR | COVIDIEN/FORMERLY TYCO HEALTHCARE | 1011001773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |