Catalog Number 955610 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Unique identifier (udi) # reported as: (b)(4).Initial reporter facility name: (b)(6) medical center.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 before priming, a green foreign matter was observed inside the housing of a polyflux 210h.There was no patient involvement associated with the reported event.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection with the naked eye showed that the product wet.A green particulate was observed on the fibre bundle.The reported failure was verified.The material analysis of the particulate matter showed that the material was polypropylen.The most likely cause for the green particle is a defective transport box in production.A nonconformance has been opened to address this issue.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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