FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0MM CUFFED TRACHEAL TUBES
MDR report key: 2843801
·
Received October 25, 2012
Report
- Report Number
- 2183502-2012-00496
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- September 25, 2012
- Report Date
- October 24, 2012
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- BTR
- 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 MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE CUFF WAS FOUND LEAKING AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. THE TUBE WAS REPLACED 6 HOURS AFTER CUFF LEAKAGE WAS NOTED. THERE WAS NO REPORT OF INCIDENT RELATED MEDICAL SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX 8.0MM CUFFED TRACHEAL TUBES | BTR | SMITHS MEDICAL MD, INC. | NA | 2227710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |