Catalog Number 1C8687 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.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 broken clearlink bag spike adapter was identified during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The sample was received for evaluation.A visual inspection was performed using the naked eye and showed that the tubing separated from the luer activated valve part.The reported issue was verified.The cause is related to the manufacturing process.Actions taken were implemented after the lot was manufactured and are currently in place and running at manufacturing process for this product to mitigate and detect the condition.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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