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, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(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 infiltration occurred while using unspecified bd¿ catheter.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that the needles are dull causing the skin to fold over the needle when trying to insert.It was also reported that they are difficult to thread off, they're blowing veins when advancing, and having to restick patients every 24 hours or so to put in a new iv.Customer response: thank you for your reply.The 20g seen to be the main problem.I had to switch to 22g due to failure rates with the 20¿s.I will keep the information on any new caths that have issues with insertion.My other concern is the fact that the catheters are only lasting 1 to 2 days sometimes as little as a few hours.Turn pink and or infiltrate.New antiseptic covers have seem to help soon.
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