FDA Adverse Event
Injury
Summary report: N
SHILEY DCT
MDR report key: 1024366
·
Received April 2, 2008
Report
- Report Number
- 2936999-2008-00148
- Event Type
- Injury
- Date Received
- April 2, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- HENEQUEN
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TUBE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNKNOWN. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. A MANUFACTURING CAPA IS ALREADY IN PLACE TO ADDRESS CUFF LEAKS.
Description of Event or Problem · 1
A DOCTOR REPORTED A SHILEY DCT TRACHEOSTOMY TUBE WITH A CUFF LEAK. THE TUBE WAS DISCARDED AND HE DID NOT KNOW THE LOT NUMBER. IT IS NOT KNOWN IF THE CUFF LEAK WAS FOUND DURING PRE-TEST OR AFTER INSERTION ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY DCT | TRACHEOSTOMY TUBE | BTO | HENEQUEN | DCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |