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.The 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 use of excessive force.Due to this information a supplier corrective action request (scar) was issued against supplier.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (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 the connection to the epifuse connector.Per the anesthetists, they have not been overtightening lock.No patient injury was reported.
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Search Alerts/Recalls
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