Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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.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 when using the unspecified bd arterial cannula, the device caused infection, sepsis, thrombosis, hematoma, pseudoaneurysm and bleeding.There were no reports of specific patient results or histories related to the product.The following information was provided by the initial reporter."it was reported via survey response the the clinician experienced localized infection (15), abscess (15), pseudoaneurysm (13), hematoma (18), and bleeding (8) when used for insertion." "it was reported via survey response the the clinician experienced localized infection (56), abscess (56), hematoma (54), and bleeding (58), when used for arterial blood pressure monitoring." "it was reported via survey response the the clinician experienced thrombosis (15), sepsis (52), abscess (32), pseudoaneurysm (26), hematoma (21), and bleeding (3) when used for serial arterial blood gas determination.".
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