Date of event: unknown.The date received by manufacturer has been used.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.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.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.Capa is not required at this time.
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It was reported that unspecified bd¿ venflon catheter was used and the clinician experienced infections on 7 occasions, phlebitis on 14 occasions, infiltration on 5 occasions, and leakage on 31 occasions,.The following information was provided by the initial reporter: it was reported via venflon pmcf survey that the clinician experienced cannula related bloodstream infection (e.G.Blood stream bacteraemia, sepsis),phlebitis, infiltration, extravasation (not related to high pressure injection of contrast media), cannula occlusion, extravasation with high pressure injection of contrast media within the past 2 months.
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