Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is one of two reports.Refer to 9611594-2021-00143 for the second report.It was reported that a ng (nasogastric) tube was placed and the stylet was difficult to remove and caused tearing of the tube when removed.Another tube was placed.Additional information has been requested.
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One used sample was returned for evaluation.Testing of the sample occurred after decontamination.No leaks, tears, or holes were found during testing.The complaint could not be confirmed as reported.No root cause was determined.All information reasonably known as of 01 dec 2021 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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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