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: bd was unable to perform a thorough investigation as no 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.Capa is not required at this time.
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It was reported that there was an infection on 3 occasions while using unspecified bd" insyte autoguard catheter.There were also reports of extravasation on 45 occasions, and needle stick injuries on 3 occasions.The following information was provided by the initial reporter: it was reported via post market survey that the clinician encountered bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (3), phlebitis (12), infiltration / extravasation (45), catheter occlusion (96), needlestick injury - after use on patient - after safety mechanism activation (3).
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