Catalog Number 302151 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Injury (2348)
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Event Date 03/15/2018 |
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 and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that the needle cover of a bd¿ syringe with needle was not covered, creating a sterile breach.The user was injured by the exposed clean needle.There was no report of exposure or medical intervention.
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Manufacturer Narrative
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Investigation results: no photos or samples were returned.Root cause could not be determined.If samples are received in the future the complaint will be re-opened and re-investigated.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Reviewed syringe device history record (dhr) and no quality notification was raised for the reported batch.No formal corrective action will be needed.
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Search Alerts/Recalls
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