FDA Adverse Event
Malfunction
Summary report: N
SHILEY LOW PRESSURE CUFFED
MDR report key: 1521009
·
Received October 30, 2009
Report
- Report Number
- 2936999-2009-00740
- Event Type
- Malfunction
- Date Received
- October 30, 2009
- Date of Event
- September 3, 2009
- Report Date
- September 30, 2009
- Manufacturer
- COVIDIEN/ FORMERLY TYCO HEALTHCARE
- Product Code
- BTO
- PMA / PMN Number
- K811033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION WAS REQUESTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE TRACHEOSTOMY TUBE IN THE PT ON OR NEAR (B) 96) 2009. ON (B) (6) 2009, THE PT WENT TO THE HOSPITAL WHERE THE PHYSICIAN OBSERVED THE CUFF WAS DEFLATED. HE ATTEMPTED TO INFLATE THE CUFF WITH 20 ML/AIR WITHOUT SUCCESS. THERE WAS NO INFO PROVIDED REGARDING ANY REQUIRED MEDICAL INTERVENTION. IT IS NOT KNOWN IF THE PT REQUIRED RE CANNULATION AS USE OF THE TUBE SHOULD NOT EXCEED TWENTY-NINE DAYS AND THE TUBE SHOULD HAVE BEEN REMOVED ROUTINELY BY (B) (6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY LOW PRESSURE CUFFED | TRACHEOSTOMY TUBE | BTO | COVIDIEN/ FORMERLY TYCO HEALTHCARE | 0812000093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |