Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).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 unspecified bd connecta experienced 5 cases of loose/separated/detached stopcocks/caps, and 3 cases of kinked tubing.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of no flow or reduced flow of fluids (10), stopcock inadvertently disconnects from mating component (5), and the tubing kinked (3).
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