It was reported that the bd¿ pre-filled normal saline syringe leaked during use.The following information was provided by the initial reporter, translated from chinese: "the child was admitted to the hospital due to poor reaction after birth.On (b)(6) 2022, the indwelling needle was sealed for the child after infusion.When using the flush, fluid leakage was found.The conical head cap may not be tightly sealed.The other flush was replaced immediately and no harm was done to the patient.".
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 1334701.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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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