FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0 MM VOCALAID TRACHEOSTOMY TUBE
MDR report key: 3881264
·
Received February 18, 2014
Report
- Report Number
- 2183502-2014-00038
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- January 20, 2014
- Report Date
- February 17, 2014
- 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
SMITHS MED HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MED WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. EXPLANATION OF METHOD CODE: THE ACTUAL DEVICE INVOLVED WAS RETURNED AND IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER FIVE HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MED SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101373 | PORTEX 8.0 MM VOCALAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL INTERNATIONAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |