A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of (b)(6) 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.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).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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Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the third of four reports.Refer to 8030647-2020-00119 for the first report.Refer to 8030647-2020-00120 for the second report.Refer to 8030647-2020-00122 for the fourth report.It was reported that the closed suction catheter had a loose connection and "popped off" at patient connection.There was alarm awareness and the catheter was reapplied or switched out for another like closed suction catheter.No patient injury or adverse events reported.
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