Catalog Number 2B8012 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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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 the part of an intravia bag that seals the port, described as the diaphragm, separated from the device and was floating in the solution.This occurred when spiking the bag and filling with solution.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was not returned and the lot number is unknown; 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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