Catalog Number 2000E CHINA |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the ll vlv adpt(stand alone) experienced foreign matter in fluid path.The following information was provided by the initial reporter: during surgical, foreign matter were found at the joint screw.There were photos and samples could be returned, and 1 was affected.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 8/24/2021.H.6.Investigation: one 2000e china sample from lot 21025825 was received in open packaging for investigation; no residual fluid was present in the sample.A visual inspection confirmed the customer's experience as a brown contaminant was identified to be embedded within the plastic on the inner side of the male luer.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the moulding process did not identify a definitive root cause for contamination of this nature; however it is likely that the contamination was caused by burnt material which may have occurred on startup of the moulding process.In such instances the initial components are typically segregated and disposed of, however in this instance it is likely that the affected component was not segregated and continued onto subsequent assembly processes due to human error.A review of the production records for lot 21025825 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The production personnel have been informed of this complaint in order to be aware of the reported failure mode during future production of this product.
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Event Description
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It was reported that the ll vlv adpt(stand alone) experienced foreign matter in fluid path.The following information was provided by the initial reporter: during surgical, foreign matter were found at the joint screw.There were photos and samples could be returned, and 1 was affected.
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Search Alerts/Recalls
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