FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1828184
·
Received September 1, 2010
Report
- Report Number
- 2936999-2010-01159
- Event Type
- Injury
- Date Received
- September 1, 2010
- Date of Event
- July 14, 2010
- Report Date
- August 2, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). APPLICABLE 510K# FOR U.S DISTRIBUTED PART IS K791045. THE CUSTOMER INDICATED THAT THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED TO THE MFG SITE FOR ANALYSIS. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE SAMPLE ANALYSIS, 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 TUBE DEVELOPED A CUFF LEAK DURING PATIENT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | HI-LO TRACHEAL TUBE WITH LANZ | BTR | COVIDIEN, FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |