The actual complaint product was not returned for evaluation.The device history record for lot 30153030 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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 two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 9611594-2023-00058 for the second report.Fda medwatch / fda user facility report mw report mw5115942 reported, ¿we have had two instances of patients with gastric-jejuna! tubes in place that have been fed/received medications into the wrong location due to changes in the product.The product previously had the jejunal port as the straight port and the gastric port as the side port.In a recent change by the manufacturer, the port locations have been swapped.This change has been further complicated by the rubbing off of the text that labels the ports as either gastric or jejunai.
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