Catalog Number 6304 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Event Description
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Report received of a bristle disengagement.Report stated a nurse was using the suction oral brush during a demonstration led by a sales representative when three bristles disengaged inside her mouth.The nurse was able to easily remove the bristles from her mouth.The nurse did not experience any adverse consequences.The lot number was provided for evaluation; however, the involved device was discarded by the facility.Although requested, no additional information was available.
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Manufacturer Narrative
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Involved device was discarded by facility and no photos were available of the the involved device.Facility was able to provide the lot # for the involved device.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per product drawing for the quality checks performed at sage products.The suction oral brush is manufactured at a third party manufacturer, team technologies, who is currently completing an investigation of this report.Involved device discarded by facility.
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Manufacturer Narrative
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Reporter did not provide involved device or photographs of the device, therefore a visual inspection could not be completed.A product history review was completed with all checks showing a passing result.The third party supplier of the involved device was contacted for additional investigation.Their investigation showed that all sampling plans were met and deemed acceptable.
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Event Description
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Report received of a bristle disengagement.Report stated a nurse was using the suction oral brush during a demonstration led by a sales representative when three bristles disengaged inside her mouth.The nurse was able to easily remove the bristles from her mouth.The nurse did not experience any adverse consequences.The lot number was provided for evaluation; however, the involved device was discarded by the facility.Although requested, no additional information was available.
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Search Alerts/Recalls
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