Initial reporter e-mail: unknown.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1117415.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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It was reported that mildew was found on the bd posiflush¿ syringe when opening the packaging.The following information was provided by the initial reporter, translated from chinese: "the patient came to the department of gynecology of our hospital due to gynecological diseases.After the infusion was completed, the flush was used to prepare the tube sealing.After opening the flush, mildew was found on the head, and the flush was replaced immediately.".
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