(b)(4).Investigation summary: a device history record review was performed for provided lot number 8290572.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.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.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 carried out and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no sample analysis a probable root cause could not be offered.
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It was reported that the 10 ml bd posiflush¿ normal saline syringe experienced foreign matter contamination.The following information was provided by the initial reporter: purpose of use: after the patient is treated, use a flush to seal the tube to reduce pollution and reduce the risk of infection.It has little effect on the patient's condition and physiological indicators.Basis for use: follow doctor's advice; usage: before sealing the tube with the product, the medical staff found that there was a trace of foreign matter in the tube.Replace with a new flusher immediately, and report adverse events.Impact on the victim: no harm was caused; time for treatment measures: (b)(6) 2020.Take treatment measures: immediately replace with a new batch of products.
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