Catalog Number H938741 |
Device Problems
Fluid/Blood Leak (1250); Defective Device (2588)
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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)(6).Uf / importer report number: the user facility submitted this medwatch (b)(4) for this event.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 unspecified quantity of 3000ml exactamix eva tpn bags had leaked or contained defective ports.The reporter stated that an unspecified number of bags were leaking and an unspecified number of bags had defective ports.
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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 returned; 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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