Catalog Number 383511 |
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 02/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd nexiva contained foreign matter.The following information was provided by the initial reporter, translated from chinese to english: before puncturing the child, if a foreign object is found in the tube during normal inspection of the indwelling needle, replace it immediately.
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Manufacturer Narrative
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Investigation results; a device history record review was completed by our quality engineer team for provided material number 383511 and lot number 3087425.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.
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Event Description
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No additional information.
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Search Alerts/Recalls
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