FDA Adverse Event
Malfunction
Summary report: N
PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
MDR report key: 2881188
·
Received November 14, 2012
Report
- Report Number
- 2183502-2012-00551
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Report Date
- April 25, 2012
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- BTO
- PMA / PMN Number
- K083031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 1 WEEK 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 UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES | BTO - TRACHEOSTOMY TUBE | BTO | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 2218636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |