Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
Decreased Respiratory Rate (2485)
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Event Date 07/09/2022 |
Event Type
Injury
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Event Description
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It was reported that the trach tube flange broke.The trach was changed to resolve the issue.Item and lot number are unknown.Additional information was requested; however, no further specific details on this incident were received.No additional adverse effects to the patient after the trach was changed, were reported.
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Manufacturer Narrative
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Udi number, catalog number and device lot numbers are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Manufacturer Narrative
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Other, other text: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr review was not conducted since no lot number was provided.
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Search Alerts/Recalls
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