Date of event: unknown.The date received by manufacturer has been used for this field.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, (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: 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.Root cause description: no root cause can be determined as no samples were received.
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It was reported that there was an infection on 8 occasions while using unspecified bd" insyte autoguard bc pro catheter.There were also 10 occurrences of needle retraction issues.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (8), needlestick injury after use on patient after safety mechanism activation (10) and catheter occlusions (4).
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