Catalog Number 2C6204 |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
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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 eight (8) large bore stopcocks were defective.The defect was further described as packaging was not sterile, air leak from the side of the sealed edge.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: eight (8) actual samples were received for evaluation.Visual inspection was performed which observed that one sample was wrinkled and there was a part of the blister package seal that was opened.A bubble test was performed on each received sample which revealed a leak in the seal of only one sample.The reported condition was verified in one sample; however, not verified in the remaining seven samples.The cause of the condition could not be determined.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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