Investigation summary: it was reported by health professional that the patient developed hives and itchiness.To aid in the investigation, one sample with no packaging blister or tip cap was received for evaluation by our quality team.The sample is empty and the plunger rod-rubber stopper is all the way down.No defects or imperfections were observed.Since the sample is empty, no testing on the solution could be performed.A device history record review was completed for provided material number 306547, lot number 1160581.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Sterilization records also show no issues were experienced.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.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 not required at this time.
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It was reported that syr 10ml pump compatible saline 10ml fil was used and the patient developed hives and itchiness.The following information was provided by the initial reporter: it was reported by health professional that the patient developed hives, itchiness, and itchiness.Health professional called to report that yesterday, (b)(6) 2021, when nurse was flushing patients chest port the patient began to complain of itchiness and heat.Hives developed all over his body.He was given 25ml of benadryl iv.Customer is doing better, but still has some itchiness.
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