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Catalog Number H93811 |
Device Problems
Fluid/Blood Leak (1250); Cut In Material (2454)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 three (3) tube sets were slit and leaking while in use.There was no damage noted to the packaging or any other sets.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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