FDA Adverse Event
Malfunction
Summary report: N
SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE
MDR report key: 248024
·
Received September 2, 1999
Report
- Report Number
- 2029387-1999-00118
- Event Type
- Malfunction
- Date Received
- September 2, 1999
- Report Date
- July 28, 1999
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY INTERNATIONAL MALLINCKRODT FACILITY THAT INFLATION COULD NOT BE MAINTAINED ON ONE (1), SIZE 5 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE. THE DEVICE WAS TESTED PRIOR TO PLACEMENT AND HAD BEEN IN USE APPROXIMATELY ONE (1) WEEK WHEN THE INFLATION LINE BECAME SEVERED/SEPARATED. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT INJURY. THE INVOLVED 5 SCT DEVICE WAS RETURNED TO THE MFR ON 05/28/99 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | BTO | MALLINCKRODT MEDICAL, INC. | 5 SCT | M82563000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | (MFG MODEL TYPES UNKNOWN).| VENTILATOR, VARIOUS CONNECTORS/ADAPTORS |