Catalog Number 682245 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the flow switch did not work on the bd¿ arterial cannula.The following information was provided by the initial reporter, translated from (b)(6) to english: switch mechanism hangs.The closing mechanism does not lock without problems.
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Manufacturer Narrative
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H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.
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Event Description
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It was reported that the flow switch did not work on the bd¿ arterial cannula.The following information was provided by the initial reporter, translated from german to english: switch mechanism hangs.The closing mechanism does not lock without problems.
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Search Alerts/Recalls
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