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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.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.Complaints received for this device and reported condition will continue to be tracked and trended.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 that unspecified bd arterial cannulas were involved with 5 cases of sepsis, 10 cases of infection, and 15 cases of blood exposure.No device malfunction was associated with the reported serious injuries.It has not been specified whether medical intervention was administered as a result of any of the adverse events.The following information was provided by the initial reporter: it was reported via survey response the clinician experienced sepsis (5), localized infection (10), and bleeding (15) when used for arterial blood pressure monitoring.
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