FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0 CUFFED TRACHEOSTOMY TUBE
MDR report key: 1850483
·
Received September 21, 2010
Report
- Report Number
- 2183502-2010-00410
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Report Date
- September 17, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 4 TO 5 HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX 8.0 CUFFED TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | BTO | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 904326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |