The avanos medical inc.Investigation confirmed the device was a cortrak nasogastric (ng) tube; the registration site for the device is 9611594.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.The root cause could not be determined.All information reasonably known as of 12 may 2023 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.H3 other text : device not returned.
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Avanos medical inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the fourth of five reports.Refer to 9611594-2023-00064 for the first report.Refer to 9611594-2023-00065 for the second report.Refer to 9611594-2023-00066 for the third report.Refer to 9611594-2023-00068 for the fifth report.Medwatch/ fda user facility mw report (b)(4) reported a safety event involving cortrak tube placement resulting in iatrogenic pneumothorax, the patient¿s current condition was not reported.
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