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 Date 07/21/2015 |
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 reporter stated that the broken part of the diaphragm did not enter the primary line that the bag was attached to.The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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