FDA Adverse Event
Injury
Summary report: N
SHILEY LOW PRESSURE CUFFED
MDR report key: 2010496
·
Received March 1, 2011
Report
- Report Number
- 2936999-2011-00098
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 4, 2011
- Manufacturer
- COVIDIEN/ FORMERLY TYCO
- Product Code
- JOH
- PMA / PMN Number
- K962173
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. A FAILURE INVESTIGATION WILL BE PERFORMED ON THE RETURNED SAMPLE. IF SIGNIFICANT INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A SIZE 8LPC TRACHEOSTOMY WAS INSERTED INTO THE PT IN THEATRE, BUT WHEN THEY PUT THE INNER CANNULA INSIDE, THERE WAS A LEAK AROUND THE CONNECTOR. THE CANNULA WAS REMOVED AND REPLACED WITH A SIZE 10LPC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LOW PRESSURE CUFFED | TRACHEOSTOMY TUBE | JOH | COVIDIEN/ FORMERLY TYCO | 1009000367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |