Catalog Number H938737 |
Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/13/2017 |
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 a 250ml exactamix eva tpn bag had a damaged additive port.The damage was found before use of the device.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed and noted a damaged additive port cap.The cap was cracked.The reported issue was confirmed.The cause of the reported issue 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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