Catalog Number 100/391/116CZ |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A sample was received to perform an investigation.Visual inspection found that the luer lock connector was separated from filter body.Each flat filter has retention ring which is designed to hold luer lock connected with filter.Retention ring and luer lock connector on the sample were found to be without any damage.Retention ring and luer lock hole diameters were measured under camera system.It was found that retention ring was slightly undersized and luer lock hole diameter was within specification.Undersized retention ring might cause reported luer lock connector detachment without using of excessive force.Due to this finding, supplier corrective action request (scar) was issued against the supplier.A device history review (dhr) could not be performed as the lot number was unknown.(b)(4).
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Event Description
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It was reported that the luer locking mechanism on the epidural filter came off the filter and loosened connection to the connector.Per anesthetists, they have not been overtightening the lock.No patient injury was reported.
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Search Alerts/Recalls
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