(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 94102.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.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Root cause description: based on the investigation results, an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.
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It was reported that the bd posiflush¿ normal saline syringe tip was damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: "after the patient¿s infusion, when the nurse closed the picc for the patient, the connector of the flush was damaged, immediately return to the treatment room to replace with a new one.".
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