Catalog Number 515070 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer's address is unknown.(b)(6) usa has been used as a default.The initial reporter also notified the fda on 23 august, 2021.Medwatch report # mw5103168.Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that connector c35-o came apart.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported that the connector comes apart when administering medication that requires a filter and a different connector is used when this occurs.
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Manufacturer Narrative
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Investigation: no samples or photos received for investigation.Five retained samples from the same lot were evaluated, after a visual inspection of all retained samples requested; no issues were observed on the luer cone nor the luer thread.No damages can be observed on retained samples requested.Functional testing was performed, penetrating the injector along with a sample syringe and mating components ten times, all results were found to be acceptable with no leaks identified.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
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Event Description
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It was reported that connector c35-o came apart.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported that the connector comes apart when administering medication that requires a filter and a different connector is used when this occurs.
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Search Alerts/Recalls
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