Catalog Number 682245 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Event Description
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It was reported bd arterial cannula 20g had a damaged catheter.The following information was provided by the initial reporter, translated from (b)(6): "the catheter tubing of the indwelling needle was ruptured when the artery indwelling needle was indwelled to the patient.".
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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