Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter phone #: (b)(6).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported that 5 bd connecta¿ multiflo¿ 3-way multiple infusion manifolds experienced air bubbles/air in line.The following information was provided by the initial reporter: we have been informed of a malfunction when using a 3v ll connecta rot 360° ref 394601.Indeed, our neonatology department reports that 4 hours after the assembly of the nutrition tree including your tap, bubbles of a consequent size appeared in the tubing and dispersed in the extension.However, the purge was carried out before connection.This event occurred 5 times in the year 2021 with different breakers and pumps.
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