(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 19-nov-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).The device was not returned.
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The patient reports that while suctioning himself the catheter caused him harm and he "bleed" and he experienced pain in his chest.The patient also says that the device does not reach the base of the trachea and it goes only so far; therefore, he has to push the catheter to make it reach further, causing him to lose air, feel asphyxia and headache.Additional information received 06-nov-2020 from the patient stated the problem with that catheter is the elbow shape, it is because the base where it connects to the tracheostomy is small.That's why the air escapes and suffocates [me] "because the oxygen does not pass completely into the lungs through that escape and neither does it stay fixed in the position that you connect it, but as time goes by it turns little by little." additionally, the accordion shape tube connected on the side of the catheter that connects to the sleeve of the ventilator, that sends air through the trachea towards the lungs, moves from side to side.
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