Model Number 383556 |
Device Problem
Material Perforation (2205)
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Patient Problem
Pain (1994)
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Event Date 08/01/2022 |
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 bd nexiva closed iv catheter system experienced the needle broke through the catheter.The following information was provided by the initial reporter: the needle had broken through the plastic catheter.
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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system experienced the needle broke through the catheter.The following information was provided by the initial reporter: the needle had broken through the plastic catheter.
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Manufacturer Narrative
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H.6.Investigation summary: the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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