It was reported that 8 unspecified bd¿ arterial cannulas caused localized infections during use.Additionally, 1 cannula caused an air embolism, and 1 cannula caused permanent ischemic damage.There was no further report of patient impact.The following information was provided by the initial reporter: "it was reported via survey response the clinician experienced localized infection (8) and air embolism(1) when used for insertion" "it was reported via survey response the clinician experienced.Permanent ischemic damage (1) localized infection (1) when used for arterial blood pressure monitoring".
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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.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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