FDA Adverse Event
Malfunction
Summary report: N
PORTEX 7.5MM VOCALAID TRACHEOSTOMY TUBE
MDR report key: 3012705
·
Received February 22, 2013
Report
- Report Number
- 2183502-2013-00046
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Report Date
- February 21, 2013
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: ONE USED SAMPLE WAS RECEIVED FOR EVAL. VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND AN INDENTATION ON THE CHECK VALVE LUER CONNECTION; HOWEVER, FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THE DEVICE WAS FOUND TO OPERATE AS INTENDED; NO EVIDENCE WAS FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS LEAKING DURING USE. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78794 | PORTEX 7.5MM VOCALAID TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBES | CAZ | SMITHS MEDICAL INTERNATIONAL LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |