Catalog Number 2N3350 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that the filter of two(2) non-dehp micro-volume extension sets were cracked and leaked.This was identified during priming.The sets were used with medfusion syringe pumps.There was no patient involvement.No additional information is available.
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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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Manufacturer Narrative
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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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