Model Number 20-0950 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Pneumothorax (2012)
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Event Date 05/11/2022 |
Event Type
Injury
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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 not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 10 jun 2022 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.Device not returned.
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Event Description
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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 3011270181-2022-00043 for the second report.A pneumothorax was reported.No additional information was provided concerning the patient¿s current condition.
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Event Description
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Additional information received on 16jun2022 reported that, to the best of the reporter¿s knowledge that the patient was injured but did recover.Additionally, the policy was to order an x-ray after every placement.
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Manufacturer Narrative
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All information reasonably known as of 30 jun 2022 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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Manufacturer Narrative
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H6: investigation findings (appropriate term/code not available): user, training issue.The actual sample from the reported event was not returned for evaluation; however, a potential misplacement was visible on the mu screen (via the provided tracing(s)), along with confirmation from the reporter that the user was not trained at bedside and had not completed the minimum number of supervised placements; the root cause was determined to be "user: incorrect use." the device history record for lot 1204001 was reviewed and the product was produced according to product specifications.All information reasonably known as of 29 jul 2022 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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Manufacturer Narrative
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All information reasonably known as of 12 apr 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 reported event but is relaying the information 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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Search Alerts/Recalls
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