(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 79152.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 cannot be identified.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.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.With no sample analysis a probable root cause could not be offered.
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It was reported that the syringe 5ml saline fill experienced leakage.The following information was provided by the initial reporter: on (b)(6) 2020, when the indwelling needle was sealed to the patient, the nurse found that the outer packaging of the flush was leaking, and it was replaced immediately without causing adverse effects.
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