The tubing that was kinked, showed that the connector which connects the delivery tube was sealed off from the rest of the cannula tubing.This caused the infant to not receive ventilation.Although, there is a possibility of patient harm the infant did not show any adverse event from the lack of ventilation.Based on the reported information the criteria for reporting an adverse event have been met.
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The tubing that was kinked, showed that the connector which connects the delivery tube was sealed off from the rest of the cannula tubing.This caused the infant to not receive ventilation.Although, there is a possibility of patient harm the infant did not show any adverse event from the lack of ventilation.Based on the reported information the criteria for reporting an adverse event have been met.Still pending the receival of the returned product for cc6742.We were unable to confirm this complaint since we did not have any in-house product to review nor did we have any pictures.We reviewed the batch record for this lot and there was nothing indicating that the tubing was received in as damaged.Based on how the product is packaged it is unlikely that the product was kicked during transit.However, if the product was packaged with the tubing on the side rather than beneath the bag, it could have become kinked and permanently deformed due to the high temperatures experienced during transit.I was unable to replicate the defect described without twisting the tubing in a way it was not intended to be twisted.This is part of our product design validation.The tubing used for the resus product line has 3 ribs on the inside of the tubing that are required for iso compliancy, see below.These ribs prevent the tubing from being completely closed and ensures that there is still o2 supply to the patient.We're going to close these complaints at this time pending product return.No cc or nc associated with this defect in 1 year.Ra: o2 occluded is listed as 6 6- major.
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