FDA Adverse Event
Malfunction
Summary report: N
UNSPECIFIED TRACHEAL TUBE
MDR report key: 11095322
·
Received December 30, 2020
Report
- Report Number
- 2936999-2020-00992
- Event Type
- Malfunction
- Date Received
- December 30, 2020
- Date of Event
- November 21, 2020
- Report Date
- December 30, 2020
- Manufacturer
- BICAKCILAR GLOBAL TIBBI URUNLER AS
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562413 | UNSPECIFIED TRACHEAL TUBE | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | BICAKCILAR GLOBAL TIBBI URUNLER AS | UNSPECIFIED TRACHEAL TUBE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |