Catalog Number 2C8519 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device manufacturer address 1: (b)(6).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 brown specks were stuck to the tubing of a clear-link system continu-flo solution set.The customer stated that, "it was hard to tell if it was melted plastic or if it was effecting the integrity of the tubing." this was identified prior to use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed contamination - particulate matter (pm) in the tubing.The pm was identified as irregular brown flecks embedded in multiple areas in the tubing due to a piece of burned plastic in the tubing.The reported condition of contamination was verified.The cause of the condition is manufacturing related.No additional defects were observed during inspection.The reported condition of damaged set-malformed 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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