Catalog Number H938739 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 clear clips of four (4) 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition)bags would not close properly.It was further reported that pliers were used in order to close them.This issue was identified during unspecified process step.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: upon follow-up, the customer clarified that there was no allegation against this product code h938739.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 h4 and h6.H4: the lot was manufactured from april 23, 2020 - april 24, 2020.H10: 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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Search Alerts/Recalls
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