Catalog Number H938737 |
Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/26/2017 |
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 the fill port of a 250ml eva tpn bag was cracked internally where the port is fused to the container.This was discovered before compounding.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.A visual inspection was performed and found that the fill port was defective and cracked internally where the port had been fused.The reported problem 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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