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.Fda device problem code: (b)(4).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.Rationale: capa is not required at this time.
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It was reported that unspecified bd¿ catheter was used and caused reactions.This was discovered during use.The following information was provided by the initial reporter: catheter in stop of marketing for one year.Same reactions (pain, induration, inflammation).Withdrawal at d4 and stop of central venous catheters.
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