Based on the investigation of the returned device and the information provided by the local distributor, we evaluate this issue as follows: according to the physical appearance of the device and the given information, the period of application was longer than instructed in the ifu as the maximum.Additionally the patient used other cleaning agents as prescribed in the cleaning instructions, which most likely might have taken an abrasive effect to the material.Conclusion: no indication for a product error found.An application error has to be assumed.The neck plate of the tracheostomy tube is located outside the body (non-invasive) and therefore the alleged detachment of the nack plate cannot have caused the asserted bleedings.A detaching of the tube from the neck plate is a long-term process and will not happen all at once.Several warnings in the enclosed ifu state that the device may not be used any longer, if the material of the device appears to be discoloured or damaged.Additional explanation: the reporting of this matter was delayed due to electronic reporting issues and the report is now being submitted on february 17, 2017 following the resolution of those issues on february 13, 2017.
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