(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0017764.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.Investigation conclusion: based on the investigation carried out and with no sample for analysis the symptom reported by the customer could not be confirmed.This lot was produced for 1.3mm units; therefore, the cpm is 0.77.Root cause description: no sample was received; no photo was provided; with no sample analysis a root cause couldn¿t be offered.Rationale: 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 the bd posiflush¿ syringe plunger was found broken and could not be used.The following information was provided by the initial reporter, translated from (b)(6) to english: "the patient was admitted to the hospital on (b)(6) 2020 due to "department, expectoration, and wheezing for 1 year, and aggravation for 5 days".The admission diagnosis was bronchial asthma.After admission, due to poor blood vessels, in order to protect the blood vessels and reduce the number of punctures, intravenous indwelling needles were used for infusion.(b)(6) 2020 after the infusion, the nursing staff sealed the patient's intravenous indwelling needle.After activation, the outer packaging was removed.During the operation, it was found that the plunger of flush was broken and could not be used.So immediately replaced another flush to complete the operation did not cause adverse effects on patients.".
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