FDA Adverse Event
Injury
Summary report: N
SHILEY LASER ORAL TRACHEALTUBE DUAL CUFFED MURPHEY EYE 4.5MMID 7.0MMOD
MDR report key: 23750057
·
Received December 8, 2025
Report
- Report Number
- MW5180134
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- August 19, 2025
- Report Date
- December 2, 2025
- Manufacturer
- COVIDIEN
- Product Code
- BTR
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE CUFF OF THE ENDOTRACHEAL TUBE WAS TOO BULKY AND STIFF FOR A TUBE THIS SIZE DESIGNED FOR PATIENTS OF THIS AGE. THEY DO NOT COLLAPSE ENOUGH TO EASILY FIT THROUGH THE GLOTTIC OPENING OF YOUNG CHILDREN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2797489 | SHILEY LASER ORAL TRACHEALTUBE DUAL CUFFED MURPHEY EYE 4.5MMID 7.0MMOD | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | COVIDIEN | 86397 | 202405175X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male | Hospitalization |