FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1852464
·
Received September 29, 2010
Report
- Report Number
- 2936999-2010-01232
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 31, 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), THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K # FOR UNITED STATES DISTRIBUTED PART IS K841872. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR ANALYSIS. IF SIGNIFICANT INFO 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 A LEAK OCCURRED IN THE INFLATION LINE DURING PT USE. THE CALLER REPORTED THAT VISUAL INSPECTION REVEALED A TEAR ON THE INFLATION LINE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | 7.0 REINFORCED TRACHEAL TUBE | BTR | COVIDIEN, FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |