FDA Adverse Event
Malfunction
Summary report: N
SHILEY
MDR report key: 11782825
·
Received May 6, 2021
Report
- Report Number
- 11782825
- Event Type
- Malfunction
- Date Received
- May 6, 2021
- Date of Event
- April 6, 2021
- Report Date
- April 28, 2021
- Manufacturer
- COVIDIEN LP
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE END OF A COVIDIEN LP SHILEY ENDOTRACHEAL TUBE (ETT) SPLIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683847 | SHILEY | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | COVIDIEN LP | 86233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 365 DA |