Catalog Number H938174 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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 an exactamix set had contamination.The event was further described by the reporter as that a lock of hair was found in the overpouch.The event occurred before use; therefore, 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.Visual inspection identified a small black fiber/hair inside the lower left quadrant of the overpouch.Microscopic examination revealed the particle to be a fiber.The reported condition was verified.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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