(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0141766.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.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.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 device damage/deformation while still considered operable.The following information was provided by the initial reporter: when the nurse was sealing the tube for the patient, he found that the flush was broken and could not be used normally, so he immediately replaced it.
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