FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
MDR report key: 2123554
·
Received June 9, 2011
Report
- Report Number
- 2183502-2011-00468
- Event Type
- Malfunction
- Date Received
- June 9, 2011
- Date of Event
- April 22, 2011
- Report Date
- June 7, 2011
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 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 8.0MM SUCTIONAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | JOH | SMITHS MEDICAL INTERNATIONAL LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |