FDA Adverse Event
Injury
Summary report: N
SHILEY LOW PRESSURE CUFFED
MDR report key: 2040951
·
Received March 25, 2011
Report
- Report Number
- 2936999-2011-00233
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- February 11, 2011
- Report Date
- March 3, 2011
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K962173
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. RETURN OF THE TRACHEOSTOMY TUBE FOR INVESTIGATION WAS REQUESTED BUT IT HAS NOT BEEN RETURNED TO DATE. IF RETURNED, A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION 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 CUSTOMER REPORTED THAT THE INTERNAL CANNULA CAME UNLOCKED AND SLID OUT OF THE EXTERNAL CANNULA OF THE PATIENTS TRACHEOSTOMY TUBE. THE PATIENT WAS RE CANNULATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LOW PRESSURE CUFFED | TRACHEOSTOMY TUBE | JOH | COVIDIEN/FORMERLY TYCO HEALTHCARE | 1004001446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |