FDA Adverse Event
Malfunction
Summary report: N
PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
MDR report key: 3192423
·
Received June 19, 2013
Report
- Report Number
- 2183502-2013-00327
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Date of Event
- May 14, 2013
- Report Date
- June 18, 2013
- Manufacturer
- SMITHS MEDICAL MD, INC.
- 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 EVALUATION. 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 EVALUATION.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT ALLEGES THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER THREE HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279291 | PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | JOH | SMITHS MEDICAL MD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |