Catalog Number H938738 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the middle spike port.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was manufactured from april 30, 2019 - may 02, 2019.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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Manufacturer Narrative
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Additional information was added to (update to evaluation method code and evaluation result code).The actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed which revealed spike port cap leakage at the base of the spike port tubing.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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