BAXTER HEALTHCARE - MOUNTAIN HOME EFFLUENT SAMPLE BAG; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number T5C4476 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/17/2018 |
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 there was a missing connector cap on the yume set drain bag.This was noticed, prior to use, before opening the pouch.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.A visual inspection with the naked eye revealed the connector was missing from the blue cap in the unopened pouch.The reported condition was verified.The cause of the condition was manufacturing related.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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