FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1990880
·
Received February 10, 2011
Report
- Report Number
- 2936999-2011-00104
- Event Type
- Injury
- Date Received
- February 10, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 11, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PART NUMBER# 112-10 IS NOT DISTRIBUTED IN THE US; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K871204. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF DEVELOPED A LEAK DURING PATIENT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. THE TUBE WAS REPLACED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | HI-LO TRACHEAL TUBE | BTR | COVIDIEN, FORMERLY TYCO HEALTHCARE | 2010038896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |