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Model Number 2270135 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.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.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 comp- (b)(4).
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Event Description
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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 events.This is the third of five reports.Refer to 8030647-2020-00092 for the first event.Refer to 8030647-2020-00093 for the second event.Refer to 8030647-2020-00095 for the fourth event.Refer to 8030647-2020-00096 for the fifth event.It was reported the closed suction catheter was popping off the trach during use.There was no reported injury.
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Manufacturer Narrative
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The device history record for the reported lot number, 30059295, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 04-jan-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, 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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Search Alerts/Recalls
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