FDA Adverse Event
Injury
Summary report: N
SHILEY LOW PRESSURE CUFFED
MDR report key: 2160555
·
Received July 6, 2011
Report
- Report Number
- 2936999-2011-00425
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 13, 2011
- Manufacturer
- COVIDIEN / FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K961273
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE TUBE WAS DISCARDED. NO ANALYSIS CAN BE MADE WITHOUT THE DEVICE. THE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 8LPC LOCKING DEVICE OF INNER CANNULA BROKE AND INNER TUBE COULD NOT BE LOCKED IN. THE TUBE WAS REMOVED AND DISCARDED. THE PT REQUIRED RECANNULATION WITH ANOTHER UNSPECIFIED TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LOW PRESSURE CUFFED | TRACHEOSTOMY TUBE | JOH | COVIDIEN / FORMERLY TYCO HEALTHCARE | 1101000345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |