FDA Adverse Event
Malfunction
Summary report: N
SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE.
MDR report key: 298211
·
Received September 26, 2000
Report
- Report Number
- 2029387-2000-00119
- Event Type
- Malfunction
- Date Received
- September 26, 2000
- Date of Event
- August 1, 2000
- Report Date
- September 21, 2000
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, THAT "THE CUFF LEAKED." THERE WAS NO REPORTED INJURY AND/OR CHANGE IN THERAPY. THE INVOLVED DEVICE(S) HAVE NOT BEEN RETURNED TO THE MFG FACILITY FOR ANALYSIS AND INVESTIGATION AS OF THE DATE OF THIS REPORT. PLEASE REFERENCE MEDWATCH REPORT #2029387-2000-106;2029387-2000-116;2029387-2000-117; AND 2029387-2000-118 FOR ADDITIONAL EVENTS INVOLVING THE SAME PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. | TRACHEOSTOMY TUBE | BTO | MALLINCKRODT MEDICAL, INC. | 10FEN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | VENTILATOR DEPENDENT (MFG. TYPE/MODEL NOT KNOWN). |