Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the customer had a flange break on the trach tube.Item and lot number are unknown.No patient injury or adverse affects were reported.
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Manufacturer Narrative
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Pma/510(k), 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: h6: event problem and evaluation codes: updates not required.H10: 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.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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Manufacturer Narrative
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H10: 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.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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Search Alerts/Recalls
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