Catalog Number FNC3220N |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/06/2020 |
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 the tubing of a continu-flo blood/solution set was cut near the y-site of the clearlink.The cut tubing was discovered in the packaging prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added: the device was received for evaluation.Visual inspection was performed which observed that the tubing was disconnected.The reported condition was verified.The cause of the condition was determined to be an assembly issue during manufacturing.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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