FDA Adverse Event
Malfunction
Summary report: N
AIRCARE ENDOTRACHEAL TUBE
MDR report key: 21772862
·
Received April 4, 2025
Report
- Report Number
- 21772862
- Event Type
- Malfunction
- Date Received
- April 4, 2025
- Date of Event
- March 11, 2025
- Report Date
- March 20, 2025
- Manufacturer
- WELL LEAD MEDICAL CO.,LTD
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
VENT WAS INDICATING LEAK. ATTEMPTS TO TROUBLE SHOOT WERE UNSUCCESSFUL. DECISION MADE TO EXCHANGE ETT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1263648 | AIRCARE ENDOTRACHEAL TUBE | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | WELL LEAD MEDICAL CO.,LTD | 100/102/075 | 2104020807275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Male |