FDA Adverse Event
Malfunction
Summary report: N
SHILEY SPECIALIZED CUFFLESS TRACHEOSTOMY TUBE
MDR report key: 176093
·
Received July 7, 1998
Report
- Report Number
- 2029387-1998-00066
- Event Type
- Malfunction
- Date Received
- July 7, 1998
- Date of Event
- October 1, 1997
- Report Date
- May 28, 1998
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TWO (2) M4CFS DEVICES AND A SIZE 14FR. SUCTION CATHETER WERE RETURNED TO THE MANUFACTURER ON 09/10/98 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. THE MANUFACTURER'S EVALUATION RESULTS ARE RECORDED IN SECTION H. OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY SPECIALIZED CUFFLESS TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | BTO | MALLINCKRODT MEDICAL, INC. | M4CFS | M66367000; M76215000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | VENTILATOR,| 14FR. SUCTION CATHETER (MFG. MODEL TYPES UNKNOWN)| VARIOUS CONNECTORS/ADAPTORS, |