It was reported that unspecified bd xs syringe experienced 3 cases of air embolism, 3 cases of exposure to bloodborne pathogens, 1 case of infection, 1 case of leakage which led to hazardous drug or fluid exposure, 1 case of mucocutaneous blood exposure, 3 cases of particulate embolism, a case of sepsis infection, and a case of crbsi infection.The following information was provided by the initial reporter: reported air embolism, exposure to bloodborne pathogens, localized infection, leakage leading to hazardous drug / fluid exposure, mucocutaneous blood exposure, particulate embolism, sepsis, systemic infection/crbsi.
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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).(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.Bd was unable to perform a thorough investigation as no item number, sample, lot, or batch number were provided.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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