AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL; VAP MICROCUFF ENDOTRACHEAL TUBES
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Model Number 35116 |
Device Problem
Material Deformation (2976)
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Patient Problem
Unspecified Respiratory Problem (4464)
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Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not available for return.A review of the device history record is in-progress.All information reasonably known as of 21 mar 2024 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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Event Description
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Avanos medical inc.Received a single report that referenced 3 different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 3011270181-2024-00039 for the first report.Refer to 3011270181-2024-00040 for the second report.A reoccurring problem was reported; per google translate: "during the surgical block, as soon as the intubation tube has been at body temperature, it becomes very flexible and folded at the corners of the lips, resulting in an obstruction and making ventilation difficult.The pressure build-up alarms allowed us to quickly realize the situation." there was no reported injury. .
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Manufacturer Narrative
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The device history record for lot was reviewed and the product was produced according to product specifications.Without a sample, to perform a functional evaluation, it is not possible to confirm or duplicate the reported incident; therefore, the root cause is undetermined.All information reasonably known as of 13 may 2024 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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