Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.\initial reporter phone #: an additional phone # was provided as (b)(6).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 connectas experienced 5 cases of leakage, 1 case of tubing separation from adapter/luer connector, and 4 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 leakage (5), tubing disconnects from stopcock (1), and the tubing kinked (4).
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