FDA Adverse Event
Malfunction
Summary report: N
PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
MDR report key: 2050085
·
Received April 4, 2011
Report
- Report Number
- 2183502-2011-00134
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- January 4, 2011
- Report Date
- March 30, 2011
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL, LTD.
- Product Code
- BTO
- PMA / PMN Number
- K083031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
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 AN UNKNOWN AMOUNT OF TIME IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES | BTO - TRACHEOSTOMY TUBE | BTO | SMITHS MEDICAL INTERNATIONAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |