Date of event: unknown.The date received by manufacturer has been used as a default.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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It was reported that while using unspecified bd neoflon¿ iv cannula, 10 patients got infections which required medical intervention.The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered cannula related bloodstream infection (e.G.Blood stream bacteraemia, sepsis)".
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