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: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Material number and batch number is unknown; a lot history review could not be performed.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 unspecified bd¿ syringe was used and the patient experienced feeling cold, a fever 37.5, and then on repeat 38.2.Session ended early.The following information was provided by the initial reporter: we have had a small number of patients in the last few weeks who have had rigors and/or fever towards the end of their haemodialysis/apheresis session or just after disconnection.All patients affected have central venous catheters.Cultures and infection screens are reported negative."30mins before end of session c/o feeling cold, temp 37.5 then on repeat 38.2, ended session early.".
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