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 26-nov-2018 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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).
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It was reported that a catheter stretched out to where the luer lock fell off.According to the doctor and the nursing guidance, the decision was made to remove the catheter while the patient was in the post-anesthesia care unit.When post-anesthesia attempted to pull out the already stretched catheter, part of it broke in situ.No further information received at this time.
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