Investigation summary: it was reported the outer package was leaking.As a sample was not returned, a thorough sample investigation could not be completed.The packaging flow wrap is considered a dust cover and intentionally has perforations.The sterile component is the solution inside of the syringe.A device history record review was completed for provided material number 306594, lot number 1105721.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.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.
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It was reported by the customer that during use of the bd posiflush¿ syringe, the outer package was leaking.The following information was provided by the initial reporter: "the patient needed to use a flush due to his condition.On may 15, 2022, the nursing staff found that the outer package was leaking when using it, so he replaced it with a new one.".
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