Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported when using the unspecified bd arterial cannula, the device experienced infection and air embolism.The following information was provided by the initial reporter.It was reported via survey response the clinician experienced localized infection (3), and air embolism (1).
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