FDA Adverse Event
Malfunction
Summary report: N
SHILEY LOW PRESSURE CUFFED
MDR report key: 1941995
·
Received October 21, 2010
Report
- Report Number
- 2936999-2010-01244
- Event Type
- Malfunction
- Date Received
- October 21, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K962173
- Removal / Correction Number
- Z-1480-2010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE TUBE IS NOT AVAILABLE FOR EVALUATION. (B)(4) IS APPLICABLE TO THE LOT NUMBER PROVIDED FOR THE REPORTED TUBE.
Description of Event or Problem · 1
THE COVIDIEN REPRESENTATIVE IN (B)(4) RECEIVED A NOTICE FROM THE (B)(6) ON (B)(6) 2010. THE NOTICE WAS REGARDING A REPORT (B)(4) HAD RECEIVED IN (B)(6) 2010. DUE TO (B)(6) POLICY, NO DETAILS REGARDING PATIENT OR EVENT ARE RELEASED. THE REPORT WAS SENT TO COVIDIEN (B)(4) AS NOTIFICATION OF THE REPORTED FAILURE MODE AND THE MODEL OF TUBE. THE REPORT CONTAINED THE TUBE MODEL AND LOT NUMBER AND STATED THE FAILURE WAS REGARDING A LEAK IN THE PILOT BALLOON SEAM. NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LOW PRESSURE CUFFED | TRACHEOSTOMY TUBE | JOH | COVIDIEN/FORMERLY TYCO HEALTHCARE | 0905001388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |