Catalog Number 2C6204 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the packaging of three (3) large bore stopcock with rotating male luer lock were defective and unsterile with air leak.This was observed prior to use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: three (3) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A bubble test was performed on each received sample and no defects or seal damage was identified.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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